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

Catalog Number VBH061002W

Device Problem Separation Failure (2547)

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

Event Date 08/07/2021

Event Type  malfunction  

Manufacturer Narrative

The following manufacturing records were reviewed in tungsten/mdis: 23041443; 23041442; qc testing batch 2/28/2021-a; qc testing batch 3/2/2021-c; zipper components 22924532, 22949324.A review of the manufacturing records indicated the device met pre-release specifications.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

The following was reported to gore: on (b)(6) 2021, a patient was to be implanted with a 6mm x 10cm gore® viabahn® endoprosthesis with heparin bioactive surface(viabahn device) to treat superficial femoral artery disease.After the viabahn device was advanced to target lesion, the physician tried to pull out the deployment line.However, it got stuck at half when the viabahn device expanded 1/3.Therefore, it was removed out of patient and another 6mm x 5cm viabahn device(vbh060502w) was used to completed the procedure.The patient tolerated the procedure and no complications.

Manufacturer Narrative

H6: code 213-evaluation of the returned product indicates damage to the as-returned, fully expanded endoprosthesis as well as kinks in the delivery catheter.The cause of the reported deployment difficulty could not be confirmed as the device was returned in a fully expanded state.The entire device was returned, and the endoprosthesis was separate from the delivery catheter and fully expanded as-returned.The outer zipper is completely unzipped.The deployment line is exposed at the hub and transition.Length measurements were not attempted because the deployment line is tangled.The deployment knob was returned but was not attached at the hub indicating deployment was likely initiated.The distal shaft is kinked 4.5cm from the transition.The dual lumen is kinked approximately 4.5cm from the hub.Tape delamination and bent struts were observed on the endoprosthesis approximately 2cm from the distal end.The video file attached to the complaint shows an entire vsx device on a surface with several procedure supplies.Observations from the video are listed below, but no conclusions regarding product performance can be drawn because the environment shown in the video does not represent the product use environment.The dual lumen of the delivery catheter is bent sharply near the location where it is being held.The red staining of the endoprosthesis indicates prior blood contact.The endoprosthesis is approximately one-third expanded, and the delivery catheter is kinked acutely at the proximal end of the endoprosthesis.In the video, when a person pulls on the deployment line, the dual lumen recoils on itself and no further expansion of the endoprosthesis occurs.

Manufacturer Narrative

H6: added component code g4: added.H10: there is no need to include phr results referring to tungsten/mdis.The investigation including evaluation of images and the returned device could not confirm the cause of the reported issue of this event.

• 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: pixie xi ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12437593
• MDR Text Key: 270319032
• Report Number: 2017233-2021-02341
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2022

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 Expiration Date: 02/23/2024
• Device Catalogue Number: VBH061002W
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2021
• Initial Date FDA Received: 09/08/2021
• Supplement Dates Manufacturer Received: 08/16/2021; 03/01/2022
• Supplement Dates FDA Received: 12/22/2021; 03/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male