GORE-TEX VASCULAR GRAFT WLG211 V470401

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-02-23 for GORE-TEX VASCULAR GRAFT WLG211 V470401 manufactured by W.l. Gore & Associates.

Event Text Entries

[402803] Approx 4 days following implant of a gore-tex vascular graft in the forearm for dialysis access, the pt presented with an ischemic hand. The graft was removed.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 680208
• MDR Report Key: 680208
• Date Received: 2006-02-23
• Date of Report: 2006-02-23
• Date of Event: 2005-08-25
• Date Facility Aware: 2006-01-23
• Date Reported to Mfgr: 2006-01-23
• Date Added to Maude: 2006-03-02
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: GORE-TEX VASCULAR GRAFT
• Generic Name: EPTFE VASCULAR PROSTHESIS
• Product Code: FIQ
• Date Received: 2006-02-23
• Model Number: WLG211
• Catalog Number: V470401
• Lot Number: 03758081
• ID Number: NA
• Device Expiration Date: 2010-06-19
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 669477
• Manufacturer: W.L. GORE & ASSOCIATES
• Manufacturer Address: 1505 NORTH FOURTH ST. FLAGSTAFF AZ 86004 US
• Baseline Brand Name: THINWALLED GORE-TEX STRETCH VASCGRAFT CONFIG FOR PEDIA.SHUNT
• Baseline Generic Name: EPTFE VASCULAR PROSTHESIS
• Baseline Model No: WLG211
• Baseline Catalog No: ST05010
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2006-02-23