MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE-TEX STRETCH VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 05/10/2018

Event Type  Injury  

Manufacturer Narrative

The date of implant (b)(6) 2012, is a best estimate based on the information "on (b)(6) 2018, after about 6 years".

Event Description

The eptfe prosthesis was implanted in 2012 as an axillo-bifemoral bypass in order to treat ischemia.On (b)(6) 2018 after about 6 years, a segment of the prosthesis was explanted due to infection (positive to propionibacterium acnes).

Manufacturer Narrative

A2: added patient date of birth.A4: added patient weight.B5: updated event description.B7: added other relevant history.H6-code 4112: analysis of data provided by third party is ongoing.H6-code 4119: the lot number of the device was requested, but was not provided.The lot number remains unknown.

Event Description

The eptfe prosthesis was implanted in 2012 as an axillo-bifemoral bypass in order to treat ischemia.In 2014 an aorto-bifemoral bypass was implanted.On (b)(6) 2018, the patient was treated for acute ischemia due of obstruction of the left upper limb.On (b)(6) 2018, the axillo-bifemoral bypass was ligated.On (b)(6) 2018, about 6 years after implantation, the left part of the axillo-bifemoral bypass prosthesis was explanted because of infection positive to propionibacterium acnes.Additionally the patient underwent antibiotic therapy to resolve the infection.

Manufacturer Narrative

B5: updated event description.

Event Description

A ringed gore-tex® stretch vascular graft (graft) was implanted in 2012 as an axillo-bifemoral bypass in order to treat ischemia.On (b)(6) 2018, the patient was treated for acute ischemia due of obstruction of the left upper limb of the graft.On (b)(6), 2018, the graft was ligatured.On (b)(6) 2018, about 6 years after implantation, the proximal part of the garft was explanted because of infection positive to propionibacterium acnes.Additionally the patient underwent antibiotic therapy to resolve the infection.

Manufacturer Narrative

H6-code 213: the explant was investigated by a third party.Their report was reviewed by gore.The gore explant evaluation summary states the following: the fragment was largely devoid of tissue with minimal scattered plaques of thin layer tan/yellow tissue on the abluminal surface.Extremity a of the fragment was ligatured thus the patency of the fragment could not be verified.The fragment was transected at both ends.Extremity b transection was consistent with cutting via surgical instruments (e.G., scalpel, scissors), which were likely used during the explant procedure.Extremity a was ligatured with blue running suture (presumed during the graft ligation procedure reported on (b)(6) 2018).Two bends were present in the fragment, causing the lumen to be narrowed in shape.The other bend had an area that was described by geprovas as, ¿abnormal eptfe¿, which was surrounded by friable tissue.Serration marks were present and multiple rings were missing or displaced on the fragment, which were caused via surgical manipulation.The serration marks are consistent with surgical instruments (e.G., forceps, clamps), which were likely used during the explant procedure.The "abnormal eptfe/thickened" areas noted by geprovas (noted as ¿abnormal eptfe in level 1 analysis) appeared to be a combination of radial film and tissue interaction in areas with physiologic motion and anatomical bend (presumed [via ct imaging] interaction with costal bones), resulting in superficial trapped biologic debris and bunching of the radial film along the ring edges.There is no evidence that this finding impacted device performance.This finding is consistent with what would be expected for a device in this application.The material disruptions observed were consistent with those caused by either manipulation from surgical instrumentation (e.G., toothed forceps, clamps) or in-vivo wear, which had no evidence of impact on device performance.

• Brand Name: GORE-TEX STRETCH VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8905364
• MDR Text Key: 154703332
• Report Number: 2017233-2019-00665
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K903931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR
• Patient Weight: 60