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

Catalog Number SRRT06060080L

Device Problem Obstruction of Flow (2423)

Patient Problem Obstruction/Occlusion (2422)

Event Date 02/15/2023

Event Type  Injury  

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.H6 evaluation codes investigation findings c19 belongs to the product history review: a review of the manufacturing records indicated the lots met all pre-release specifications (manufacturing/packaging/boxing/sterilization).H6 evaluation codes type of investigation b13: additional information in regard to the event of the case was requested from the physician.The provided additional information is captured in the event description in section b5.H3: other code: the medical device returned to a third party for further investigation.The analysis report was shared with gore and is being evaluated appropriately.Further investigation is being conducted and will be included in the final report.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

It was reported to gore that the patient presented urgently to the vascular surgery department by his angiologist on (b)(6) 2023, with worsening pain in the right lower limb with no trophic disorders or sensory-motor deficits.On (b)(6) 2023, a thrombo-embolectomy of the superficial femoral artery and the right popliteal artery was performed.On (b)(6) 2023, the patient presented with acute ischaemia and motor deficit of the right lower limb and underwent a prosthetic sub-articular femoro-popliteal bypass with a gore-tex® stretch vascular graft thin walled removable rings.On (b)(6) 2023, a follow-up doppler ultrasound revealed obstruction of the bypass at its origin.Thrombectomy of the femoro-popliteal bypass combined with angioplasty of the right anterior tibial artery was performed.The post-operative follow-up was unfavourable, with the leg remaining ischaemic and deficient.Amputation was therefore decided on (b)(6) 2023.After amputation, the patient presented with an episode of rectal bleeding and acute renal failure.He, was then transferred to a re-education and functional rehabilitation establishment and then to an establishment for the elderly.

Manufacturer Narrative

Explant evaluation: the device fragment was returned to gepromed for investigation.Submitted in formalin was a gore-tex® stretch vascular graft ¿ thin-walled removable ringed prosthesis.The scope and results of the investigation were summarized, and a report was submitted to w.L.Gore & associates.An explant scientist at w.L.Gore & associates reviewed the report.The graft fragment was reported to measure approximately 99 mm in length with both ends transected.Blue alignment marks were faintly visible along the graft fragment.The abluminal surface was covered in minimal, scattered plaques of red-brown biologic material.At the mid-body of the graft fragment, light yellow to yellow multifocal plaques of biologic material were adhered to the abluminal surface.The lumens at extremity a and extremity b of the fragment were occupied with light tan to red biologic material.The patency of the graft fragment could not be confirmed based on the analysis or images provided.Material disruptions (e.G., transections) were consistent with those caused by surgical instrumentation (e.G., scalpel, scissors) during the surgical amputation or explant process.In the instruction for use for the gore-tex® stretch vascular graft the following is stated: possible complications with the use of any vascular prosthesis complications which may occur in conjunction with the use of any vascular prosthesis include but are not limited to: thrombosis.

• Brand Name: GORE-TEX® STRETCH VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• 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: 17681873
• MDR Text Key: 322609728
• Report Number: 2017233-2023-04252
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00733132612383
• UDI-Public: 00733132612383
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K933943
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SRRT06060080L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2022
• 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: 86 YR
• Patient Sex: Male