MAUDE Adverse Event Report: VASCUTEK LTD. GELWARE; GELWEAVE EXTRA LONG BIFURCATE

Model Number GELWEAVE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ischemia (1942); Necrosis (1971)

Event Date 04/16/2014

Event Type  malfunction  

Event Description

The event was reported to vascutek as follows: acute ischemia following right popliteal and leg axis occlusion at 4 hours post op.First right toe necrosis.Surgeon performed inter renal aorta thrombectomy and bilateral bypass.Doctor performed right popliteal and right leg axis thrombectomy with fogerty catheter.

Manufacturer Narrative

Results: qc and manufacturing records show device was manufactured to specification.

• Brand Name: GELWARE
• Type of Device: GELWEAVE EXTRA LONG BIFURCATE
• Manufacturer (Section D): VASCUTEK LTD.; newmains ave.; inchinnan business park; renfrewshire, scotland PA4 9RR; UK PA4 9RR
• Manufacturer Contact: steven arick ; 6200 jackson road; ann arbour, MI 48103-9300 ; 7346634145
• MDR Report Key: 3998743
• MDR Text Key: 20013116
• Report Number: 9612515-2014-00005
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K964665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: GELWEAVE
• Device Catalogue Number: 731608XL55
• Device Lot Number: 316477 5587
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/27/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other