MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number PAHR091502E

Device Problem Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2024

Event Type  malfunction  

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.E1: initial reporter name: (b)(6).H3: other code: the medical device is available, but was not returned for further investigation yet.H6 evaluation codes investigation findings c19 refers to the product history review: a review of the manufacturing records indicated the device met pre-release specifications.Further investigation is being conducted and will be included in the final report.Heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.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 underwent endovascular treatment for a popliteal artery aneurysm (paa) with two gore® viabahn® endoprostheses with propaten bioactive surface (vsx-device).It was stated that the first vsx-device was placed successfully, however when the distal vsx-device was placed in position and the deployment knob was pulled it didn¿t deploy.It seemed impossible to complete the extraction and the vsx-device did not open.They retracted the vsx-device in the cook flexor sheath and removed it from the patient.Another vsx-device was used and the procedure was completed successfully.There was no report of patient harm.

Manufacturer Narrative

Engineering investigation: the engineering evaluation report details observations made directly on the returned device in addition to device photos captured during evaluation.The viabahn® device was returned to gore for evaluation, and deployment of the inner zipper had not been initiated.The evaluation has observed the deployment mechanism to be functional: the deployment line was not caught on any part of the device and deployment continued during evaluation.The cause for the reported deployment difficulty could not be established.Procedural deployment of the device can be impacted by different factors including but not limited to zipper integrity, delivery system support or stiffness, or presence of dried fluid on the device or within the catheter dual lumen.The investigation could not confirm the cause of the reported hazardous situation nor the primary device failure mode potentially associated with this event.The root cause of the reported failure mode of inability to deploy could not be established with the available information.The root cause of the observed exposed distal shaft and shifted endoprosthesis is consistent with device withdrawal or other manipulation during procedure.In the instruction for use for the gore® viabahn® endoprosthesis with propaten bioactive surface the following is stated: hazards and adverse events; device related: complications and adverse events can occur when using any endovascular device.These complications include, but are not limited to: deployment failure.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18985237
• MDR Text Key: 338672225
• Report Number: 2017233-2024-04757
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: IT
• PMA/PMN Number: P040037
• 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: 05/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PAHR091502E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: 05/01/2024
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2023
• 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: 83 YR
• Patient Sex: Male
• Patient Weight: 90 KG