MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE PROPATEN VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number HT087080A

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/29/2020

Event Type  Death  

Manufacturer Narrative

Additional manufacturer narrative: cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

The following was reported to gore: on (b)(6) 2020, the presented for axillofemoral bypass using a gore® propaten® vascular graft.It was reported ten days post operative the patient expired.The physician stated the patient expired due to multi organ failure and hemorrhagic shock.The physician also stated the multi organ failure and hemorrhagic shock was suspected to have been caused by a complete transection/disruption of the proximal end of the graft 4cm distal to the anastomoses.

Manufacturer Narrative

H1/h2 corrected type of reportable event.

• Brand Name: GORE PROPATEN VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 11323226
• MDR Text Key: 231661968
• Report Number: 2017233-2021-01666
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00733132606849
• UDI-Public: 00733132606849
• Combination Product (y/n): Y
• 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: 06/14/2021

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: 05/30/2024
• Device Model Number: HT087080A
• Device Catalogue Number: HT087080A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/12/2021
• Supplement Dates Manufacturer Received: 06/14/2021
• Supplement Dates FDA Received: 06/14/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention