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

Catalog Number PAH110502E

Device Problems Material Fragmentation (1261); Separation Failure (2547)

Patient Problem Stenosis (2263)

Event Date 02/23/2021

Event Type  Injury  

Manufacturer Narrative

The patient age was asked but not provided.The device remains implanted, but the delivery catheter was requested and received for further investigation.A review of the manufacturing records indicated the lot met pre-release manufacturing 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

It was reported to gore that patient underwent endovascular treatment for a stenosis in the iliac artery with a gore® viabahn® endoprosthesis with propaten bioactive surface (viabahn-device).It was stated that deployment was initiated, and the viabahn-device deployed but began to stuck in the last 5-10 mm.The deployment line could not be pulled anymore and the prosthesis was not deployed over the whole length.It was reported that after a bit of manipulation the viabahn-device was deployed completely.The deployment line came out of the sheath, but was still fixed at the prosthesis.The catheter could be removed and the physician tried to remove the deployment line, but with no success.It was stated that an additional surgery was needed.With a retroperitoneal access technique the deployment line could be removed and the patient is doing fine.

Manufacturer Narrative

Product investigation report conclusion: the specific cause of this complaint could not be determined.A product history review was conducted for the vsx device in this complaint, and the review of the manufacturing records indicated the lot met pre-release manufacturing specifications.The investigation confirms both a fraying and a cut deployment line.The complaint description also confirms partial deployment with deployment line fragments remaining in the patient with the implanted endoprosthesis.There are possible design and manufacturing causes for these failure modes which are related to the deployment line, but the specific cause is unable to be established.

Manufacturer Narrative

Updated section b1 to include 'product problem (e.G., defects/malfunctions)'.Updated section h6 to include component code 'device deployer, 788'.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN 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: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11513042
• MDR Text Key: 240597150
• Report Number: 2017233-2021-01773
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00733132627752
• UDI-Public: (01)00733132627752(17)221227
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/27/2022
• Device Catalogue Number: PAH110502E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2019
• 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
• Treatment: 11FR TERUMO INTRODUCER SHEATH.; 11FR TERUMO INTRODUCER SHEATH
• Patient Outcome(s): Required Intervention
• Patient Sex: Female