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

Catalog Number JHJR052502J

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Thrombosis (2100)

Event Date 09/01/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: device thrombosis occurred one month post initial implant procedure ((b)(6) 2018).Since the exact date of event cannot be identified, (b)(6) 2018 will be determined as the date of event.A review of the manufacturing records for the device could not be conducted as lot number of the reported device was not available.According to the gore® viabahn® endoprosthesis instructions for use (ifu), device- and/or procedure-related complications and adverse events include, but are not limited to thrombosis or occlusion.

Event Description

On (b)(6) 2018, the patient underwent endovascular repair of an occlusive lesion in the left superficial femoral artery and was implanted with non-gore manufactured bare-metal stent and a gore® viabahn® endoprosthesis (jhjr052502j with an unknown lot number).The patient tolerated the procedure.One month post initial implant procedure, the patient admitted to the hospital due to claudication.An ultrasonography was run, confirming that the existing gore® viabahn® endoprosthesis had occluded.On (b)(6) 2018, a reintervention was performed to treat the endoprosthesis occlusion.Pre-procedure angiography was run, confirming thrombosis from the proximal end of the bare-metal stent to the distal end of the gore® viabahn® endoprosthesis.Thrombectomy was performed and non-gore manufactured vascular stents were implanted inside the gore® viabahn® endoprosthesis.Thrombus partially remained, so plain old balloon angioplasty (poba) was further performed.Thrombus still existed inside the endoprosthesis, but the physician elected to monitor the patient and completed the reintervention procedure.

• 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: yutaka uchiya ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8036573
• MDR Text Key: 126067284
• Report Number: 2017233-2018-00660
• 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: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: JHJR052502J
• 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; Required Intervention
• Patient Age: 60 YR