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

Catalog Number PAC091002E

Device Problems Material Deformation (2976); Activation Failure (3270)

Patient Problem Aneurysm (1708)

Event Date 06/15/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A review of the manufacturing records indicated the lot met pre-release manufacturing specifications.

Event Description

It was reported to gore that patient underwent endovascular treatment for a popliteal artery aneurysm left with a gore® viabahn® endoprosthesis (viabahn-device).It was stated that the physician started with a little opening from superficial femoral artery (sfa) left, inserted the first viabahn-device, deployed it and removed the shaft.Everything was ok.It was reported that it was noticed, that one more stent graft was necessary to treat all the disease.The viabahn-device was advanced to the lesion and during the beginning of the deployment, the string was blocked.In addition, it was noticed that the proximal marker was very far from the stent, approximatively 4 cm.It was decided to remove the viabahn-device and to use another stent graft, however it was impossible to remove it through the introducer sheath.It was stated that the physician removed the introducer sheath first.Concerning the viabahn-device, it was a little bit open at the proximal end and it was very hard to remove it and aggressive for the artery.The patient lost 400 ml of blood in 5 minutes.Reportedly, the physician managed the blood loss, exchanged the introducer sheath and could implant another viabahn-device and treated the aneurysm successfully.Despite the blood loss, there were no consequences for the patient.

Manufacturer Narrative

Engineering evaluation: the complaint reports a stuck deployment line during attempted deployment, a shifted endoprosthesis, followed by complications during withdrawal of the device.Observations of the returned device indicate damage to the proximal end of the endoprosthesis and the distal end of the sheath.These observations are consistent with difficulty attempting to withdraw the device through the introducer sheath.A fine fiber was also observed which initially prevented deployment from continuing during evaluation.Removal of the fiber allowed deployment to continue.It is not known whether this fiber existed in the zipper prior to the procedure or resulted from subsequent damage to the device.This investigation is unable to confirm the reported deployment difficulty given the device damage observed during engineering evaluation.The entire device was returned stuck in the sheath.Deployment line: the deployment line was intact as-returned.There is a knot in the deployment line which broke off after light handling.The deployment line has additional knotting around exposed, proximal, endoprosthesis apices.Dual lumen: appears unremarkable.The distal shaft appears to have been bent and scraped.Endoprosthesis: the endoprosthesis was returned with the outer zipper partially deployed.The endoprosthesis is damaged at the proximal end.There was a mass on the endoprosthesis which was softened and removed, during evaluation, using water.The zipper and endoprosthesis appears twisted.A fine fiber is looped around a strand of the zipper.Traction was applied to the deployment line at the endoprosthesis; deployment did not continue when the fine fiber remained in place, but deployment continued after removal of the fine fiber.Accessories: the sheath appears damaged at the distal end.

Manufacturer Narrative

H1: type of reportable event should be "other".Review of this case revealed that according to our worldwide reporting guidelines for the gore® viabahn® endoprosthesis this case is considered as non-reportable.If a device remains on the catheter (even if its displaced), remains constrained, there is no other breakage, and there is no harm to the patient then this is not a serious injury and malfunction of our gore device.No patient injury, clinical sign, symptom or condition related to this incident was reported to gore.A new sheath was then inserted and a new viabahn device was used to complete the procedure.The patient tolerated the procedure.Therefore this case is considered as not reportable.The report is being retracted.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• 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: 12166961
• MDR Text Key: 261576728
• Report Number: 2017233-2021-02164
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/14/2022

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: 01/03/2024
• Device Catalogue Number: PAC091002E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2021
• Initial Date FDA Received: 07/14/2021
• Supplement Dates Manufacturer Received: 01/08/2022; 09/09/2022
• Supplement Dates FDA Received: 02/07/2022; 09/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2021
• 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 Sex: Male
• Patient Weight: 70 KG