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

Catalog Number PAHR052502E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/08/2021

Event Type  Injury  

Event Description

It was reported to gore that patient underwent endovascular treatment for a left side superficial femoral artery (sfa) in-stent stenosis with a gore® viabahn® endoprosthesis with propaten bioactive surface.It was stated that first a thromboendarterectomy (tea) was performed in the groin.As the vessels were really bad, the vascular surgeon needed to make an interponat from the common femoral artery (afc) to the afc/ external iliac artery and the profunda was attached to the interponat.It was reported that afterwards the endovascular recanalization of the left sfa was started with a pre-dilation of the tract with a 5 mm and 6 mm pta balloon at the proximal part.Below the landing zone a spot stenosis of the tract was noticed.To solve the issue a percutaneous transluminal angioplasty (pta) was conducted with a 4 mm balloon.The control angiography showed a nice result for the crural vessel.It was stated that the gore® viabahn® endoprosthesis with propaten bioactive surface was placed according to plan.The result was reasonable, however at the proximal part there were still a few pin-point stenosis with heavy calcification due to which the viabahn could not reach its full diameter (but less than 50%).Later on, the same day the endoprosthesis occluded and a reintervention took place where alteplase was applied and the crural vessels treated with angioplasty.The patient is still hospitalized and waiting for a vacant place in a nursing home.

Manufacturer Narrative

As the device remains implanted, no investigation on the device can be performed.A review of the product history-, the sterilization- and the heparin coating records will be performed.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Manufacturer Narrative

H6: evaluation codes investigation findings 213 refers to the product history review: a review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.The device remains implanted in the patient, therefore a device evaluation could not be performed.The information reported in the complaint does not reasonably suggest a potential malfunction has occurred.Neither clinical images enabling direct assessment of product performance nor the product itself were returned for evaluation.With the information reported to gore this investigation is considered complete, the cause of the complaint was unable to be determined.

• 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: 12868532
• MDR Text Key: 281203092
• Report Number: 2017233-2021-02569
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: NL
• 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
• Report Date: 01/13/2022

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: 03/17/2024
• Device Catalogue Number: PAHR052502E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2021
• Initial Date FDA Received: 11/24/2021
• Supplement Dates Manufacturer Received: 12/15/2021
• Supplement Dates FDA Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2021
• 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: 82 YR
• Patient Sex: Female