MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE PROPATEN® VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Catalog Number HT080040A

Device Problem Occlusion Within Device (1423)

Patient Problems Occlusion (1984); Tissue Damage (2104)

Event Type  Injury  

Event Description

On (b)(6) 2008, two gore propaten vascular grafts were implanted in a bypass procedure.Indication for treatment was gangrene.The procedure was performed in the patient's right leg, from a previously implanted graft (unknown manufacturer) to above-knee popliteal artery.A right axillary bi-femoral bypass procedure was also performed.Within one month post-implant, an occlusion led to an amputation.

Manufacturer Narrative

Two gore propaten vascular graft were implanted during same procedure (medwatch report #2017233-2014-00113).Review of device manufacturing history is still in review.

Manufacturer Narrative

Review of device manufacturing record history confirmed device met pre-release specifications.

• Brand Name: GORE PROPATEN® VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): KENDRICK PEAK MPD B/P; 4250 w. kiltie lane; flagstaff AZ 86001
• Manufacturer Contact: genevieve begay ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 3653714
• MDR Text Key: 4350395
• Report Number: 2017233-2014-00114
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2012
• Device Catalogue Number: HT080040A
• Device Lot Number: 2289591PP015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2008
• 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
• Treatment: GORE PROPATEN VASCULAR GRAFT, LOT #2158784PP005
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR