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

Catalog Number VBC130502

Device Problem Retraction Problem (1536)

Patient Problem No Code Available (3191)

Event Date 03/15/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The review of the manufacturing records verified that this lot met all pre-release specifications.

Event Description

On (b)(6) 2016, a gore viabahn endoprosthesis (vbc130502/14506192) was to be implanted in the left subclavian artery as a branching graft for treatment of distal tear after bentall and sun's procedure.The viabahn device was accessed from the right common femoral artery and advanced through a 14fr sheath via a guide wire from femoral artery to radial artery, then advanced in bareback to the target lesion after protruding from the sheath.It was stated the physician felt strong resistance during deployment, the deployment line was stuck at starting to release the inner layer of the braided constraining line so the stent was not able to expand.The physician decided to retract the device.However, the viabahn device failed in retracting from the access site due to not being able to return back into the sheath.The physician reportedly performed a new incision in the left common femoral artery, advanced the viabahn device out of the patient by the crossover technique with a help from the guide wire, another 14fr sheath and a snare, then deployed the viabahn device outside the patient with extra strength and removed the delivery catheter afterwards.During deployment outside the patient, a "bow string" due to the deployment line tension and a longitudinal compression of stent were observed.Another viabahn device of the same size was replaced to continue the procedure.

Manufacturer Narrative

An engineering evaluation for the returned device has been performed.The investigation stated that only the endoprosthesis was received for evaluation.The endoprosthesis was unremarkable.Based on the device examination performed, no manufacturing anomalies were identified.Per gore® viabahn® endoprosthesis instructions for use (ifu), a warning is given as "w.L.Gore & associates has insufficient clinical and experimental data upon which to base any conclusions regarding the effectiveness of the gore® viabahn® endoprosthesis in applications other than the endovascular grafting of superficial femoral or iliac arteries; inadvertent, partial, or failed deployment of the endoprosthesis may require surgical intervention." furthermore, it is stated that the complications and adverse events that can occur when using any endovascular device.These complications include but are not limited to deployment failure.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: helen huang ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5569368
• MDR Text Key: 42425067
• Report Number: 2017233-2016-00349
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2016

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: 07/26/2018
• Device Catalogue Number: VBC130502
• Device Lot Number: 14506192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2015
• 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): Other; Required Intervention
• Patient Age: 26 YR
• Patient Weight: 70