MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® VIABAHN® ENDOPROSTHESIS; NIP

Catalog Number JHH101002J

Device Problems Patient-Device Incompatibility (2682); No Apparent Adverse Event (3189)

Patient Problem Occlusion (1984)

Event Date 08/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4) the lot number was not provided.Therefore the udi is not available.The review of the manufacturing paperwork could not be performed as the lot number(s) were not available.According to the gore® viabahn® endoprosthesis instructions for use (ifu), device-related complications and adverse events include, but are not limited to thrombosis or occlusion of device.

Event Description

On (b)(6) 2017, this patient underwent endovascular procedure to repair a traumatic pseudoaneurysm of the right subclavian artery using a gore® viabahn® endoprosthesis.There was a thrombotic occlusion distal to the pseudoaneurysm, and thrombectomy was performed with a fogarty catheter from the right brachial artery approach prior to a delivery of the endoprosthesis.The patient tolerated the procedure.On an unknown date around august, follow-up computed tomography (ct) showed a stenosis of the endoprosthesis.The patient was taking mono antiplatelet (bay aspirin), and plavix was additionally administered at that time.On (b)(6) 2017, it was reported that the latest ct (date unknown) confirmed an occlusion of the endoprosthesis.Noac was additionally administered.No clinical symptoms were reportedly observed, and the patient is being monitored.Reportedly, the physician suspected that the event was contributed by the patient's predisposition since the occlusion occurred even with dual-antiplatelet drugs.Also, the lesion was reportedly located near the shoulder joint, and this condition reportedly may have contributed to the event as well.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Type of Device: NIP
• 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: marcos ayala ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7030846
• MDR Text Key: 92015625
• Report Number: 2017233-2017-00596
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• 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: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: JHH101002J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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