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 05/28/2019

Event Type  Injury  

Manufacturer Narrative

A first segment of the prosthesis was explanted due to infection (positive to propionibacterium acnes) previously.This was reported with gore reference number (b)(4).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 first segment of the prosthesis was explanted due to infection (positive to propionibacterium acnes).On (b)(6) 2018 the rest of the prosthesis was explanted due to infection to klebsiella pneumonia which lasted for two months.

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.However, on (b)(6), 2018, the rest of the of the axillo-bifemoral bypass prosthesis was explanted because the patient was still presenting pain and fever.The sample was positive to klebsiella pneumonia.The patient underwent an additional 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.However, on (b)(6) 2018, the patient was still presenting pain and fever.Therefore the rest of the graft was explanted.The sample was positive to klebsiella pneumonia.The infection to klebsiella pneumonia lasted for two months.The patient underwent an additional 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.The fragment had minimal, light yellow tissue in the lumen, when looking in from extremity b.Segment 2 also had a circumferential, foci of white opaque tissue on the ablumen, near extremity b.The fragment was widely patent.The fragment was transected at both poles.The transections were consistent with cutting via surgical instruments (e.G., scalpel, scissors), which were likely used during the explant procedure.Five rings were absent at extremity a, with the adjacent two rings still attached but partially displaced.At extremity b, the wrapping film was disrupted, and serration marks were present.The disruptions identified (e.G., missing rings, disrupted film, serration marks) were consistent with manipulation via surgical instruments (e.G., forceps, clamps), which were likely used during a surgical procedure.Three holes were observed on the fragment.The holes were consistent with those caused by manipulation via surgical instruments (e.G., toothed forceps, clamps), which were likely used during the explant procedure.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: 8905366
• MDR Text Key: 154714345
• Report Number: 2017233-2019-00664
• 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,Followup
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 10/08/2019; 07/09/2020; 07/09/2020; 10/09/2020
• 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