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

Catalog Number VBH130502W

Device Problem Activation Failure (3270)

Patient Problem Perforation (2001)

Event Date 10/29/2020

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records indicated the lot met pre-release manufacturing specifications.The device was discarded, so evaluation of the actual device was unable to be completed.Images are available, and an imaging evaluation is in progress.

Event Description

The following was reported to gore: on (b)(6) 2020, a patient was to be implanted with a 13mm x 10cm gore® viabahn® endoprosthesis with heparin bioactive surface to treat right iliac artery dissecting aneurysm.The viabahn device was advanced through 12fr cook sheath over terumo stiffing guidewire from right femoral artery to target lesion.The distal end of endoprosthesis was located under the abdominal aorta and the gate of the right common iliac artery.A resistance was felt when the endoprosthesis expanded 2/3.The viabahn device got stuck and couldn't be deployed after many attempts.The patient had pain in the right iliac region, and the endoprosthesis shrank to 6.6cm in length.To seal the entry of right common iliac artery, another 13mm×5cm viabahn device was to be implanted.Before use, the physician checked 13mm×5cm viabahn device without any problem.However it also couldn't be deployed when the endoprosthesis expanded 1/2.The two viabahn device partially expanded and the sealing of entry wasn't ideal.The patient with cerebral hemorrhage was unable to antiplatelet.Therefore, he was sent to the operating room to remove two viabahn devices by surgery.

Manufacturer Narrative

H6: code 3233 ¿the images received cannot be used to perform a full imaging evaluation.The extent and accuracy of the observations and findings may be limited due to the completeness, format and/or quality of the available images provided for review.Gore cannot guarantee the images provided are accurate or lack alteration.Therefore, gore cannot guarantee all key findings have been captured or that the findings are accurate.The imaging evaluation summary was preformed by imgaing team as below.One time-point available for evaluation: limited intra-operative angiogram fluoroscopy runs.No fluoroscopy runs available that include the actual deployment of device(s).With available imaging, cannot confirm more than one device is deployed.The distal portion of the device(s) does not appear to be fully expanded.All visualized portions of vessels (rci, rei) appear to be patent.There appears to be flow throughout the implanted device(s).Last angiogram clip appears to show a catheter being advanced from the proximal rci toward the rei.Per markers on the catheter, it appears there is pushing/pulling of the catheter and it does not appear to be advanced in the distal (unexpanded) portion of device(s).The device was discarded, evaluation based on event description is in progress.

Manufacturer Narrative

H6: 213 - the manufacturing records were reviewed and the device lot met all pre-release specifications.While the images received could not be used to perform a full imaging evaluation, it did confirm that at least one endoprosthesis was partially deployed.The root cause for the partial deployment of the endoprosthesis could not be determined with the currently available information.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

• 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: 10873171
• MDR Text Key: 217364121
• Report Number: 2017233-2020-01473
• 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: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2022
• Device Catalogue Number: VBH130502W
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/29/2020
• Initial Date FDA Received: 11/20/2020
• Supplement Dates Manufacturer Received: 10/29/2020; 10/29/2020
• Supplement Dates FDA Received: 12/24/2020; 03/04/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 72