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

Model Number HT066080A

Device Problem Material Separation (1562)

Patient Problem Unspecified Vascular Problem (4441)

Event Date 01/25/2021

Event Type  Injury  

Manufacturer Narrative

Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium apl, which in covalently bound to the device surface and is essentially|non-eluting.

Event Description

The following was reported to gore: on an unknown date (7months ago) a gore® propaten® vascular graft (vg) was placed in the superficial femoral artery for treatment of occlusion.On (b)(6) 2021, a gore® viabahn® endoprosthesis (vsx) was placed in the common iliac for treatment of stenosis.The physician was unable to gain access in the upper arm due to the diseased state of the patient's vessels.So the physician decided to gain access from the vg that was previously implanted (on an unknown date).The physician cut down into the vg and inserted a 7fr introducer sheath.The vsx was successfully deployed in the native vessel above the vg device in the common iliac.The patient did not experience any adverse consequences.On (b)(6) 2021, the patient had low ankle-brachial index (abi) and an ultra sound was performed.It was noticed that the low abi was coming from the vg and what appeared to be a separation of the graft's inner lumen.On (b)(6) 2021, the decision was made to reline the vg with a 6mm x 25cm vsx.The patient did not experience any adverse consequences.

Manufacturer Narrative

H6 - investigation findings, code updated to 3221 (no findings available).H6 - investigation conclusions, code updated to 4315 (cause not established).

Manufacturer Narrative

Corrected h6 - component code.

• 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
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11289408
• MDR Text Key: 230690005
• Report Number: 2017233-2021-01652
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00733132606641
• UDI-Public: 00733132606641
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2023
• Device Model Number: HT066080A
• Device Catalogue Number: HT066080A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other