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

Catalog Number VBJR052502A

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/18/2024

Event Type  malfunction  

Manufacturer Narrative

Cbas® 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

The following information was reported to gore: on (b)(6) 2024, a 5mm x 25cm gore® viabahn® endoprosthesis (vsx device) was placed as a post terrier tibial vein/artery fistula.With a v18 guide wire the physician had through and through wire access, through a 7fr terumo introducer sheath.After the vsx device was successfully delivered, the physician attempted to remove the delivery catheter.However, the physician felt resistance and continued to pull the delivery catheter.Upon removal of the delivery catheter form the patient, it was noticed that the distal tip was missing.With through and through wire access the physician used and uninflated balloon to push the distal tip out of the patient.Other - application and anatomical location, post terrier tibial vein/artery fistula.

Manufacturer Narrative

Section h6 updated to reflect completion of investigation.A review of the manufacturing records indicated the device lots met all pre-release manufacturing specifications.Engineering evaluation of the device could confirm the reported failure mode of broken components, distal tip separation.The reported resistance felt during the withdraw and the disturbance on the tip and the shaft are considered indicators that a bond was present at the time of manufacture.The root cause of the distal tip separation is consistent with the potential use error of forceful withdrawal of the vsx device.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.The vsx device ifu was reviewed with respect to the complaint detail for the applicable region and time period, and the following ifu statements were identified as related to the failure mode(s) in this complaint: while maintaining the position of the guidewire across the treated lesion, carefully withdraw the delivery catheter through the lumen of the endoprosthesis and remove it via the introducer sheath.Moderate resistance may be felt when the distal tip is withdrawn through the introducer sheath.Note: if, during catheter removal, the tip catches on the leading edge of the endoprosthesis or introducer sheath, a slight ¿back and forth¿ motion of the catheter or repositioning of the sheath may aid in release.Excessive or abrupt force during catheter removal may damage the endoprosthesis, delivery catheter, or introducer sheath.

• 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
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18636122
• MDR Text Key: 334550976
• Report Number: 2017233-2024-04591
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00733132623938
• UDI-Public: 00733132623938
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VBJR052502A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2023
• 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 Age: 80 YR
• Patient Sex: Male