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

Catalog Number 0650HYB0610

Device Problem Occlusion Within Device (1423)

Patient Problems Tissue Damage (2104); Vascular System (Circulation), Impaired (2572)

Event Date 05/09/2014

Event Type  Injury  

Event Description

The patient presented with severe gangrene on the left foot.An arterial occlusive critical pathology stage 4 was reported.The popliteal artery seemed to be extremely calcified.The common femoral artery and the popliteal femoral artery were isolated with the support of patches.A gore® hybrid vascular graft was implanted as a bypass on (b)(6) 2014.It was reported to gore that the gore® hybrid vascular graft occluded after the procedure and that the patient¿s leg was amputated one month later.

Manufacturer Narrative

Further investigation is being conducted and the information will be included in the final report.

Manufacturer Narrative

The review of the manufacturing records verified that this lot met all pre-release specifications.

Manufacturer Narrative

(b)(4).

• Brand Name: GORE® HYBRID VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: barbara ulrich ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4790096
• MDR Text Key: 5853071
• Report Number: 2017233-2015-00309
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K093934
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/23/2015

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: 08/08/2014
• Device Catalogue Number: 0650HYB0610
• Device Lot Number: 10590865A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/22/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/11/2015; 06/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2013
• 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): Disability
• Patient Age: 76 YR