GORE-TEX DIASTAT GRAFT D47300 UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-01-04 for GORE-TEX DIASTAT GRAFT D47300 UNK manufactured by W.l. Gore.

Event Text Entries

[21076528] Pt has had a loop fistula in her left forearm since 5/95. This has had recurring problems over the past eighteen months, but over the past week, she has had two visits to the cardiac catherization lab with thrombosis of the graft that have been opened with urokinase infusions. Despite this and the pictures taken at the most recent episode 24 hours ago, show that there is a suggestion of a residual filling defect in the venous loop of the forearm graft. It does not appear to involve the anastomosis. It appears to be ab area of a filling defect that persists after the clot has been cleared. Pt went to surgery on 11/26/96 for revision of the left forearm loop graft with a resection of a 2-1/2 cm segment of the venous limb and replacement with a interposition segment end to end eight mm. Post-op diagnosis was thrombosed fistula in the left forearm of uncertain etiology, possibile thrombosis, secondary to hemorrhage into the wall of the graft with partial collaspse of the internal lumen in a segment of the venous limb. This is what the physician dictated "the graft was dissected out. Dr opened into the graft and found that the inner material was partially collapsed and there was hematoma between the wall of the inner lumen and the external portion of the graft. Dr. Resected a segment of this graft where this inner lumen had been collapsed. Dr. Then carried out a standard thrombectomy.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 65768
• MDR Report Key: 65768
• Date Received: 1997-01-04
• Date of Report: 1996-12-09
• Date of Event: 1996-11-26
• Date Facility Aware: 1996-11-26
• Report Date: 1996-12-09
• Date Reported to Mfgr: 1996-12-09
• Date Added to Maude: 1997-02-03
• 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: 0
• 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 DIASTAT GRAFT
• Generic Name: DIASTAT VASCULAR GRAFT
• Product Code: MCI
• Date Received: 1997-01-04
• Model Number: D47300
• Catalog Number: UNK
• Lot Number: *
• ID Number: SIZE 4 - 7X45
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: UNKNOWN
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 65866
• Manufacturer: W.L. GORE
• Manufacturer Address: PO BOX 3080 FLAGSTAFF AZ 86003 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1997-01-04