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	Material Separation (1562)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Code Available (3191)
Date of Event	12/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 patient presented with an unknown etiology in the femoral artery and underwent treatment utilizing a gore® propaten® vascular graft.The physician completed the implanting procedure successfully.While the patient was in post operative recovery, it was observed that the gore® propaten® vascular graft had reportedly torn above the distal anastomosis post operatively.Further information has been requested but is not available at this time.
Additional Manufacturer Narrative
The following fields were updated to reflect additional information received: h6: clinical code, impact codes, type of investigation, investigation findings and investigation conclusions updated to reflect additional information received and completion of investigation.
Event or Problem Description
The following was reported to gore: on (b)(6) 2020, the patient presented with peripheral arterial disease in the femoral arteries and underwent an aortobifemoral bypass utilizing a gore® propaten® vascular graft.The physician completed the implanting procedure successfully.While the patient was in post operative recovery, it was observed that the patient was bleeding and was taken back to the operating room.The physician observed that the gore® propaten® vascular graft appeared torn from the anastomosis in the profunda post operatively.The physician made the following observations: part of the gore® propaten® vascular graft was still connected to the artery, and when the gore® propaten® vascular graft reportedly broke it retracted back into the tunnel that was created for placement.The physician then decided to ligate the gore® propaten® vascular graft and closed off the profunda.The procedure was completed by performing an above knee amputation.The patient tolerated the procedure and is reported to be recovering.

• 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
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: liam schultz ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11194486
• Report Number: 2017233-2021-01608
• Device Sequence Number: 14377795
• Product Code: DSY
• UDI-Device Identifier: 00733132606849
• UDI-Public: 00733132606849
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K062161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2021

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: 06/28/2024
• Device Model Number: HT087080A
• Device Catalogue Number: HT087080A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 12/18/2020
• Initial Report FDA Received Date: 01/19/2021
• Supplement Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Male