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

Catalog Number JHJR072502J

Device Problem Complete Blockage (1094)

Patient Problems Occlusion (1984); No Information (3190)

Event Date 01/25/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information was requested but not available.(b)(4).

Event Description

On (b)(6) 2017, this patient presented with a restenosis of non-gore bare metal stent (manufacturer unknown, diameter 7 mm) previously implanted in the superficial femoral artery.A gore® viabahn® endoprosthesis with heparin bioactive surface (jhjr072502j/ 16525646) was additionally implanted to repair the restenosis.Stenosis was also observed in the popliteal artery, and a cutting balloon was utilized to expand the lesion.Final angiography showed no issue, and the procedure was concluded.The patient tolerated the procedure.Dual antiplatelet therapy was performed after the procedure.On (b)(6) 2018, the patient complained of worsening of the leg symptoms.Emergent angiography confirmed the thrombotic occlusion of the endoprosthesis.On the same day, thrombectomy was performed using fogarty balloon catheters.After completion of the thrombectomy, mural thrombus was observed in the proximal of the superficial femoral artery.Therefore, a bare metal stent (smart, 7 mm x 60 mm) was additionally implanted inside the proximal portion of the endoprosthesis.After that, angiography confirmed that there was blood flow, and the procedure was concluded.The patient tolerated the procedure.The physician reported that the cause of the occlusion was unknown.

• 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: nataliya baramzina ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7257242
• MDR Text Key: 99535217
• Report Number: 2017233-2018-00087
• 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: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2020
• Device Catalogue Number: JHJR072502J
• Device Lot Number: 16525646
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2017
• 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): Hospitalization; Required Intervention