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

Catalog Number H060040A

Device Problem Break (1069)

Patient Problem Unspecified Infection (1930)

Event Date 02/27/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Review of device manufacturing record history confirmed device met pre-release specifications.Explant evaluation of returned specimen is currently in progress.

Event Description

On (b)(6) 2017, two gore® propaten® vascular grafts were implanted in an axillo-bifemoral procedure.On (b)(6) 2017, a reintervention procedure was performed due to femoro-femoral graft thrombosis.It was reported the physician was using a micropuncture needle for access, and the vascular graft tore apart.A section of the vascular graft was explanted and an interposition graft was placed.A section of the explanted vascular graft was sent to hospital lab for testing due to suspected infection.As reported, the test results were not available as the graft specimen was misplaced by user facility.A small section of the explanted vascular graft was returned to gore for evaluation.

Manufacturer Narrative

Review of device sterilization record history confirmed device met pre-release specifications.The explant evaluation state that gross and stereoscopic examination of the returned device fragment revealed no unusual characteristics outside those associated with the manipulation of the material with surgical instruments.All examined tissue specimens were consistent with scant deposition of unorganized fibrin admixed with variable amounts of erythrocytes, degenerate leukocytes, and nuclear debris.Calcification and infectious agents were not observed.

• Brand Name: GORE PROPATEN® VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): KENDRICK PEAK MPD B/P; 4250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: genevieve begay ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6447421
• MDR Text Key: 71322348
• Report Number: 2017233-2017-00173
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: H060040A
• Device Lot Number: 4622763PP031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MICROPUNCTURE NEEDLE
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 86