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

Catalog Number HT066080

Device Problem Contamination (1120)

Patient Problem Unspecified Infection (1930)

Event Date 03/03/2020

Event Type  Injury  

Manufacturer Narrative

Device evaluated by manufacturer: the medical device returned to a third party for investigation.The analysis report was shared with gore and evaluated appropriately.The investigation is still ongoing.The results will be included in the final report.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 resection of a left thigh sarcoma requiring arterial and venous reconstructions.A gore® propaten® vascular graft - thin-walled removable ringed was divided into two segments, which both were implanted on (b)(6) 2020.It was stated that the first segment (20-034) was implanted as a femoro-popliteal bypass, the second segment (20-035) was implanted as a venous bypass between the popliteal vein and the femoral vein.Reportedly, on (b)(6) 2020 after about 1 months, both segments were explanted due to infection.

Manufacturer Narrative

Phr-review: a review of the manufacturing records indicated the lot met all pre-release specifications.A review of the sterilization records indicated the lot met all pre-release specifications.Explant investigation (ei): the following is a summary of the ei observations: tissue present: yes.¿ vgf-1 (20-034): the ablumen was generally devoid of tissue, except for a foci of light tan to yellow and dark brown/red tissue of varying thickness present in the mid-region of the fragment.Both extremities had small fragments on white/tan and red/brown tissue attached via blue suture fragments.The lumen was reported as clear via a running water test.Extremity a was transected, circular, and presented with a clear lumen.Extremity b was transected and partially flattened.Dark red/brown tissue was present in the luminal view of extremity b.Rings were present on less than half of the graft fragment, from the mid-region to extremity b.Near extremity a, a pinched region of the fragment was present, with forceps marks occurring over the pinched region.¿ vgf-2 (20-035): the ablumen was generally devoid of tissue except for scant yellow/tan tissue present from extremity b to approximately mid-graft fragment.The remainder of the fragment was covered in scattered plaques of dark red/brown tissue present with rings present.A foci of light tan/white tissue was present at extremity b, attached to the fragment via blue running suture (presumptive anastomotic site).Dark red tissue was observed inside of the lumen at extremity a.The lumen was reported as clear via a running water test.Rings were present on less than half of the graft fragment.Partially circumferential blue running suture was present on the ablumen, in the region without rings.Extremity a had a beveled transection with blue suture fragments present.Extremity b had a beveled transection.The pinched region/forceps marks are consistent with grasping via surgical instrumentation (i.E., forceps), likely used during the explant procedure.The transections and sutures are consistent with surgical instrument manipulation (i.E., scalpel/scissors, sutures), likely used during a surgical procedure.Request for additional analysis: no.Reason: based on the ei¿s review of the geprovas report and reason for explant (infection), no additional analysis is requested.

• 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
• MDR Report Key: 10867976
• MDR Text Key: 217135732
• Report Number: 2017233-2020-01462
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2023
• Device Catalogue Number: HT066080
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR