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

Catalog Number HT087080J

Device Problem Break (1069)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/05/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Review of device manufacturing record history confirmed device met pre-release specifications.The explanted device was discarded at user facility.Therefore, direct product analysis was not possible.

Event Description

The following was reported to gore: on (b)(6) 2018, an axillo-femoral bypass procedure was performed using a gore® propaten® vascular graft (removable ring thin 8mm 70cm rs x 80cm).After patient was discharged from the hospital, it was reported the patient fell a few times on unknown dates.On (b)(6) 2018, the patient fell down again, causing an anastomotic disruption at the left axillary artery.The disrupted area was ballooned to arrest the hemorrhage.The gore® propaten® vascular graft was explanted and a new graft (unknown manufacturer) was implanted.The patient tolerated the procedure.The explanted graft was discarded at the hospital.As reported, the anastomotic disruption was due to the patient¿s fall.

Manufacturer Narrative

Date of event was corrected (intervention date).

• Brand Name: GORE® PROPATEN® VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7480341
• MDR Text Key: 107143655
• Report Number: 2017233-2018-00252
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2021
• Device Catalogue Number: HT087080J
• Device Lot Number: 5538537PP008
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR