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

Catalog Number VBH101502W

Device Problems Material Fragmentation (1261); Activation Failure (3270)

Patient Problem Perforation of Vessels (2135)

Event Date 07/04/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4): a review of the manufacturing records indicated the device met pre-release specifications.Cbas® heparin surface incorporates carmeda 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) 2022, a patient was to be implanted with a 10mm x 15cm gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device) to reconstruct the left common carotid artery during the fenestration procedure of thoracic aorta disease.The viabahn device was advanced via 11fr short sheath from femoral artery to target lesion.The deployment line was broken when the physician pulled out.It was reported normal effort was used and the endoprosthesis didn't expand.During the removal from patient, a big resistance was felt.The viabhan device scratched on the aortic stent and aortic wall.Therefore, it couldn't be retrieved from puncture.The physician cut down the femoral artery, the viabahn device was removed and adhesion of the intima on endoprosthesis was found.Another device was used to complete the procedure.The patient tolerated the procedure.

Manufacturer Narrative

An incomplete viabahn® device was returned, including two dual lumen segments, distal tip assembly, and a fully constrained endoprosthesis with a mass of biomaterial and a non-gore bare metal stent entangled at the proximal end.The hub assembly was not included in the device return, and there were no independent segments of deployment line returned although some deployment line was visible within the mass of biomaterial.The outer zipper was partially deployed, and deployment was successfully continued with traction at the endoprosthesis indicating no apparent issues with the zipper component.Multiple areas of torsional damage and strain deformation were present on the severed catheter segments, and there were nicks observed on the exposed distal shaft consistent with interaction with surgical tools.The endoprosthesis was longitudinally compressed approximately 9 cm toward the distal tip.Following removal of the biomaterial and bare metal stent from the distal end of the endoprosthesis, multiple rows of flared apices were observed.Evaluation of the returned items confirmed the report of deployment difficulty (i.E., broken deployment line).The device was returned with extensive damage to the delivery system, but deployment was successfully resumed with traction at the endoprosthesis indicating the zipper was not stuck.As the conditions present in the procedure could not be replicated in a laboratory setting, further evaluation of the deployment mechanism could not be conducted.However, the reported event details indicate the viabahn® device was intended for use in a fenestration procedure for reconstruction of the left common carotid artery.Moreover, the device was returned with an entangled bare metal stent at the proximal end of the endoprosthesis.The ifu includes relevant statements concerning the use of the viabahn® device in applications where the endoprosthesis is deployed within non-viabahn® bare metal stents or stent grafts as these devices may interfere with the deployment functionality.Therefore, the root cause of the deployment difficulty, including the line break, is consistent with reasonably foreseeable use error in the attempted deployment within other non-viabahn® stent or stent grafts leading to the potential for deployment failure.The reported complaint details indicate there was notable resistance during device withdrawal and abrasion of the viabahan® device on the aortic stent and vessel wall.The reported withdrawal difficulty could not be independently confirmed during device evaluation.However, the cause is consistent with a procedure-related unintended interaction with the bare metal stent during attempted withdrawal.Substantial biomaterial was entrapped within the bare metal stent, indicating reported vessel damage resulted from an interaction with the pointed edges of the deformed stent entangled at the proximal end of the viabahan® device.

• 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: 15070648
• MDR Text Key: 296287278
• Report Number: 2017233-2022-03130
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VBH101502W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 80 KG