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

Catalog Number HT060040

Device Problem Contamination (1120)

Patient Problem Unspecified Infection (1930)

Event Date 03/15/2021

Event Type  Injury  

Manufacturer Narrative

The device is available, but has still not been received at the manufacturer for further investigation.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 three years ago patient underwent surgical treatment for a pi-bypass with a gore® propaten® vascular graft above the knee.It was stated that the prosthesis worked well and was patent, until an infection occurred.It was reported that because of the perigraft reaction the prosthesis had to be explanted.

Manufacturer Narrative

Phr: a review of the manufacturing records indicated the lot met all pre-release specifications.Explant investigation: the device fragment was returned to w.L.Gore & associates for investigation.Submitted in formalin was a gore propaten vascular graft fragment (vgf).Vgf had been transected at both extremities prior to arrival at w.L.Gore & associates.A section of light tan to yellow artery was present, around the abluminal device surface.The abluminal surface had mild amounts of tan/brown fibrous, connective tissue and scant, tan/brown, adherent, soft tissue.Mild amounts of tan/brown soft tissue were observed, partially occupying the lumen.The lumen was patent (verified via running water test).Four histopathological specimens were collected from vgf and histopathologic analysis was complete.The examined sections of vgf exhibited normal healing traits of an outer covering of mature fibrous connective tissue with minimal foreign body inflammatory response along the abluminal aspect of the graft (eptfe).The observed lumina were patent with mild accumulations of fibrin thrombus.Microbial agents were observed, however, there was a lack of an inflammatory response to the microbes, which were most likely post-explant environmental contamination and overgrowth of bacteria.Vgf was subjected to an enzymatic digestion process to remove biologic debris.Following digestion, vgf was examined for material disruptions with the aid of a stereomicroscope.Multiple material disruptions were identified (i.E., transections, forceps marks, suture needling holes/pull-through holes, radial film disruption), which were consistent with those caused by interaction with surgical instruments (i.E., scissors/scalpel, forceps/clamps, suture needle), likely used during a surgical procedure.An area with multifocal radial film disruptions was also identified.The time and cause of these radial film disruptions could not be identified.The disruptions identified were not associated with handling or manufacturing process at w.L.Gore & associates.

Manufacturer Narrative

Product history review: a review of the sterilization records indicated the lot met all pre-release specifications.

• 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: 11654969
• MDR Text Key: 245937242
• Report Number: 2017233-2021-01859
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2022
• Device Catalogue Number: HT060040
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2018
• 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