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

Catalog Number PAHR071002E

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/07/2020

Event Type  malfunction  

Manufacturer Narrative

A patient information: no patient information was provided.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 in the superficial femoral artery (sfa) with a gore® viabahn® endoprosthesis with propaten bioactive surface (viabahn-device).It was stated that while physician was placing the viabahn-device in the target lesion, he had the impression that something is wrong, and that the prosthesis disconnected from the catheter.It was reported that for safety reasons the viabahn-device was changed, and that the intervention could be finished successfully with another device.It was stated that the catheter was not cut but may be operation stuff.

Manufacturer Narrative

Phr-review: a review of the manufacturing records indicated the lot met pre-release manufacturing specifications.Engineering investigation: this investigation confirms the endoprosthesis has displaced on the distal shaft.The cause of the endoprosthesis shifting on the distal shaft cannot be confirmed without additional information about the procedure, which was requested several times, but not received.H6 evaluation codes: 213 refers to the phr-review.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.

Manufacturer Narrative

H1 / h2 type of reportable event: instead of malfunction it must be "other".Correction: input from the product performance specialist, the product specialist and qa indicates that we do not consider this reportable per our reportability guidelines.This is based on the information that the physician was able to remove the constrained device without harm to the patient and the fact that the catheter was cut and not ¿broken in patient¿s body¿.Therefore this case is evaluated as non-reportable to the fda and is retracted.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 11026006
• MDR Text Key: 222080904
• Report Number: 2017233-2020-01533
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/13/2023
• Device Catalogue Number: PAHR071002E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Date Manufacturer Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1