Important Safety Alerts

Medical device manufacturer, Cook Medical, has issued a medical device safety alert concerning its Zenith Alpha Spiral-Z Endovascular Leg. The affected devices are identified as follows:

• Reference Part Number: ZISL-9-42, ZISL-9-59, ZISL-9-77, ZISL-9-93, ZISL-9-110, ZISL-9-125, ZISL-11-42, ZISL-11-59, ZISL-11-77, ZISL-11-93, ZISL-11-110, ZISL-11-125, ZISL-13-42, ZISL-13-59, ZISL-13-77, ZISL-13-93, ZISL-13-110, ZISL-13-125, ZISL-16-42, ZISL-16-59, ZISL-16-77, ZISL-16-93, ZISL-20-42, ZISL-20-59, ZISL-20-77, ZISL-20-93, ZISL-24-42, ZISL-24-59, ZISL-24-77, ZISL-24-93
• Order Number: G35955, G35956, G35957, G34508, G35959, G35960, G35961, G35962, G35963, G35964, G35965, G35966, G35967, G35968, G35969, G35970, G34409, G34410, G35971, G35972, G35973, G35975, G35977, 635976, G35980, G35981, G35982, G35983, G35984, G35985
• Lot Number: All

The manufacturer drew the users' attention to several aspects of the Instructions for Use (IFU) for the Zenith Alpha Spiral-Z Endovascular Leg that are of key importance when selecting and implanting a device. Investigation of thrombus formation and/or lumen occlusion reports for the affected products identified that the following factors have contributed to these failure:

• Compression of the flare on the ipsilateral leg within the main body gate;
• Misalignment of the ipsilateral and contralateral legs;
• Excessive overlap of the leg(s) above the main body graft bifurcation;
• Compression of the graft(s) within a narrowed / stenosed aortic bifurcation or iliac region.

The manufacturer is submitting a notification to all customers to highlight key points of the IFU pertaining to prevention of the identified contributing factors. In addition, the Planning and Sizing Worksheet has been updated to include information associated with the identified points from the IFU.

According to the manufacturer, if the instructions listed are not followed, graft compression and fabric infolding can occur, increasing the risk of a thromboembolic event and/or total occlusion of the leg graft.

Users are advised to take the following actions:

• If the users have affected product in the inventory, they may continue to use the products. No devices need to be returned.
• Patients already treated with the affected products should be followed in accordance with the current IFU.

According to the local supplier, the affected product is distributed in Hong Kong.

If you are in possession of the products, please contact your supplier for necessary actions.

Posted on 17 January 2020