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

Catalog Number JHJR060502J

Device Problem Complete Blockage (1094)

Patient Problem Occlusion (1984)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium apl, which in covalently bound to the device surface and is essentially|non-eluting.

Event Description

The following information was reported to gore: on an unknown date, this patient was implanted gore® acuseal vascular graft for dialysis shunt in the right arm.On (b)(6) 2020, the patient underwent percutaneous angioplasty.It was reported that the patient had frequent stenosis with partial calcification near the anastomotic site.(captured mpdcase-(b)(4)).On (b)(6) 2020, the patient underwent percutaneous angioplasty and gore® viabahn® endoprosthesis with heparin bioactive surface was deployed for stenosis at the shunt anastomosis.On (b)(6) 2020, it was reported that the patient complained of possible obstruction.On (b)(6) 2020, the patient underwent reintervention for thrombectomy using a fogarty catheter.(captured mpdcase-(b)(4)).The physician stated as follows: considering the occurrences, echo examination, and the nature of the thrombus, it is highly possible that a thrombus flowed from artery to the venous side and blocked the shunt.It is judged that this is not a viabahn-related complication.There is no problem with blood flow after thrombectomy.

• 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: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 10764614
• MDR Text Key: 214552891
• Report Number: 2017233-2020-01393
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2023
• Device Catalogue Number: JHJR060502J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention