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

Model Number	HT087080A
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/29/2020
Type of Reportable Event	Death
Additional 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 or Problem 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.
Additional Manufacturer Narrative
H1/h2 corrected type of reportable event.

• Brand Name: GORE PROPATEN VASCULAR GRAFT
• Common Device Name: 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
• Report Number: 2017233-2021-01666
• Device Sequence Number: 4010649
• Product Code: DSY
• UDI-Device Identifier: 00733132606849
• UDI-Public: 00733132606849
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K062161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 05/30/2024
• Device Model Number: HT087080A
• Device Catalogue Number: HT087080A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 02/12/2021
• Supplement Report FDA Received Date: 06/14/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention