MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN ENDOPROSTHESIS - 3; NIP

Catalog Number JHJR062502J

Device Problem Partial Blockage (1065)

Patient Problems Occlusion (1984); No Code Available (3191)

Event Date 09/01/2019

Event Type  Injury  

Manufacturer Narrative

Source: proceeding of the 28th annual meeting of the japanese association of cardiovascular intervention and theraprutics, mp24-008 (published in september 2019).Gore® viabahn® endoprosthesis was used during same procedure and was overlapped with first device in patient's superficial femoral artery.Device lot number was requested but not made available.(b)(4).

Event Description

The following publication was reviewed: a case of successful bail-out by fogarty catheter and high pressure dilation for acute occlusion of viabahn stent graft.This patient was (b)(6) years old female.The patient admitted to the hospital because of the left intermittent claudication.Ankle brachial index (abi) was 0.71/0.82 (right/left).Mr angiography showed 26 cm chronic total occlusion (cto) from the ostium of the left superficial femoral artery (sfa).On an unknown date on friday, endovascular procedure was performed.Two gore® viabahn® endoprosthesis with heparin bioactive surface (6 x 250mm, 6 x 50 mm) were implanted.Intravascular ultrasound (ivus) showed short half-moon shaped lumen in the endoprosthesis after post-ballooning (22 atm).Condition of the distal below knee run-off was not bad.On saturday, the patient vomited.On sunday, the patient experienced a fever (38 degrees celsius).On monday, abi was 0.28.Ultrasonography showed total obstruction of the endoprostheses full of thrombus.Fogarty catheter and additional high pressure post-dilation (30 atm) were performed for the occlusion.Two large thrombus were retrieved, and flow was recovered.Abi was now 0.82, and warfarin therapy was introduced.Two months later, abi was 0.9.No further issue was reported.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• 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: nick la fave ; 9285263030
• MDR Report Key: 9880423
• MDR Text Key: 193674938
• Report Number: 2017233-2020-00214
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: JHJR062502J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• 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
• Patient Age: 82 YR