Contaminated Heparin Used in Carmeda Coatings Applied to Selected Cardiopulmonary Bypass Products

Date: 2008-05-30

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The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional. This is duplicated text of a letter from Medtronic of Canada Ltd. Contact the company for a copy of any references, attachments or enclosures.

NOTICE TO HOSPITALS Health Canada Endorsed Important Safety Information on Contaminated Heparin Used in Carmeda Coatings Applied to Selected Cardiopulmonary Bypass Products

May 7, 2008

To: Hospital Chief of Medical Staff

Please distribute to the relevant Departments of [Surgery; Emergency Medecine, Pharmacy, Pediatrics, Anesthesia, Geriatrics, Internal Medicine, Nursing, Dentistry, Intensive Care and/or other Departments as required] and other involved professional staff and post this NOTICE in your institution.

Subject:

Urgent Medical Device Recall - Contaminated Heparin Used in Carmeda® Coatings Applied to Selected Cardiopulmonary Bypass Products

This letter is to advise you that Medtronic is recalling selected Carmeda^®1-coated cardiopulmonary bypass (CPB) products (e.g., oxygenators, reservoirs, pumps, cannulae and tubing packs) that were manufactured with contaminated heparin. Medtronic's heparin supplier recently reported that it had provided some batches of heparin to Medtronic that were contaminated with oversulfated chondroitin sulfate (OSCS). Affected CPB products have been distributed since January 24, 2008. Customers with affected products have been notified.

Background
The US regulatory agency, the Food and Drug Administration (FDA), has recently received numerous adverse event reports potentially caused by systemically administered, contaminated heparin including acute hypotension, allergic response type symptoms and death. On April 8, 2008, FDA issued an important notice to manufacturers of medical devices urging that they re-evaluate their heparin supplies using FDA-recommended test methods.

FDA scientists and independent researchers recently reported a potential biologic mechanism underlying the adverse events associated with OSCS exposure.² This work, published in the New England Journal of Medicine, presented in vitro experimentation data in which no biologic response was activated below 0.025 micrograms of OSCS per milliliter of plasma.² The applicability of these test results to OSCS exposure in heparin coatings, such as our Carmeda^®-coated products, has not been proved. However, as a precautionary measure, Medtronic has voluntarily decided to recall affected Carmeda^®-coated products because we were not able to conclusively establish that OSCS exposures resulting from the use of affected products will reliably fall below this threshold.

This investigation is dynamic and ongoing at FDA and within Medtronic. To date, we have not received any complaints related to the presence of OSCS in these affected Carmeda^®-coated lots.

A limited number of lots of Carmeda-coated products were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate (OSCS). Some of these lots were distributed to one hospital in Canada, which has been notified. The patient risk associated with the presence of OSCS in heparin-coated medical devices is not known at this time. However, the FDA has received reports of serious injury and death only in patients who have been administered injectable heparin products containing high levels of OSCS. Medtronic has not received any reports of OSCS-related adverse events arising from the use of Carmeda CPB products. It is unclear, however, if exposure to Carmeda-coated medical devices, made with comparatively small amounts of heparin, could cause adverse events similar to those observed with injectable heparin formulations. As a result, Medtronic has recalled affected Carmeda CBP products. It is estimated that this recall will require the recovery of no more than 82 items in Canada.

Medtronic Trillium^®-coated CPB products also contain heparin. A separate Medical Device Communication provides information pertaining to Medtronic's Trillium^®-coated products.

If you have any further questions concerning the execution of Carmeda-coated CBP products recall, please contact your local Medtronic Representative or Medtronic Customer Service Representative at 1-800-268-5346, Monday - Friday, 8:00 a.m. to 5:00 p.m. EST.

Medtronic of Canada Ltd. 6733 Kitimat Road Mississauga, Ontario L5N 1W3 Canada Telephone: 905-826-6020 FAX: 905-826-6620 Any suspected adverse reaction can also be reported to: Health Products and Food Branch Inspectorate HEALTH CANADA Address Locator: 2003D Ottawa, Ontario K1A 0K9 Tel: The Inspectorate Hotline 1-800-267-9675 The Reporting Form and Guidelines can be obtained from the Health Canada web site. For other inquiries related to this communication, please contact Health Canada at: Marketed Health Products Directorate email: MHPD_DPSC@hc-sc.gc.ca Tel.: 613-954-6522 Fax.: 613-952-7738

Health Canada has been notified of this action.

We understand that you depend on us to provide a reliable supply of the highest quality medical devices. We take the trust you place in us very seriously and seek to minimize impact to our customers and their patients.

Sincerely,

original signed by

Jon Olsen
Director, Sales & Marketing
Cardiovascular Products
Medtronic of Canada Ltd.

References:
1. Manufactured under license from Carmeda AB, Sweden
2. Kishimoto TK, Viswanathan K, Ganguly T, et al.Contaminated Heparin Associated with Adverse Clinical Events and Activation of the Contact System. N Engl J Med 2008;358