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

Catalog Number HT070080

Device Problem Contamination (1120)

Patient Problem Unspecified Infection (1930)

Event Date 01/18/2021

Event Type  Injury  

Manufacturer Narrative

Analysis report from third party was received and will be further investigated.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

It was reported to gore that patient underwent endovascular treatment for a claudication of the left lower limb with a gore® propaten® vascular graft thin walled.It was stated that the prosthesis was implanted on (b)(6) , 2017 as an above the knee femoro-popliteal bypass.Reportedly, on (b)(6) , 2021, after about 4 years, the proximal part of the prosthesis was explanted due to an infection.

Manufacturer Narrative

H6 evaluation codes investigation findings 213 refers to phr-review: phr-review: a review of the manufacturing records indicated the lot met pre-release manufacturing specifications.

Manufacturer Narrative

Explant scientist observations: the abluminal surface was partially covered in light tan/brown tissue with multifocal areas of dark red/brown tissue present.The observable luminal surface contained dark red/brown tissue.The luminal patency could not be determined with the information/images provided.Both extremities were transected, beveled, and ovular in manner.Blue, monofilament, running suture was present around the edge of extremity b (presumptive anastomosis).Multiple evenly spaced serration marks (consistent with forceps/clamps) were present along the segment, on the abluminal surface.The device segment was partially flattened along its length.The segment was approximately 40 mm in length and presented in a j-shape.From gross images, all material disruptions (i.E., material transections/cuts, evenly spaced serration marks, blue running suture), appear to be consistent with cutting by sharp surgical instruments (i.E., scalpel or scissors), grasping/pulling with surgical instrumentation (i.E., hemostat or forceps), and anastomotic suturing, likely used during surgical procedure(s).Request for additional analysis: no.Reason: based on the explant scientist¿s review of the geprovas report, no additional analysis is requested.The reported reason for removal was infection, type and source were not provided, additionally there was no direct association towards gore¿s device and the reason for removal from the physician.

• 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: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11542794
• MDR Text Key: 249112997
• Report Number: 2017233-2021-01787
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00733132606696
• UDI-Public: (01)00733132606696(17)201130
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: HT070080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male