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

Catalog Number JHJR050502J

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Thrombosis (2100); Stenosis (2263)

Event Date 03/05/2018

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.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 stenosis and thrombosis.(b)(4).

Event Description

On an unknown date, the patient was implanted with a bare-metal stent to treat a peripheral artery disease of the left superficial femoral artery.Later, stenosis was revealed in the existing bare-metal stent.On (b)(6) 2018, a reintervention was performed to treat the in-stent stenosis whereby two gore® viabahn® endoprostheses (jhjr051002j/(b)(4) and jhjr050502j/(b)(4) ) were implanted within the existing bare-metal stent.The patient tolerated the procedure.On (b)(6) 2018, it was revealed that the existing gore® viabahn® endoprostheses had been occluded.Thrombectomy and percutaneous old balloon angioplasty (poba) were performed to treat the endoprosthesis occlusion.Additionally, urokinase had been administered to the patient for a week post reintervention.On (b)(6) 2018, stenosis was revealed at the proximal edge of the existing gore® viabahn® endoprosthesis, and poba was additionally performed.Stenosis was resolved and the patient tolerated the procedure.

• 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: yutaka uchiya ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7340491
• MDR Text Key: 102436018
• Report Number: 2017233-2018-00172
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130006
• 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: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2019
• Device Catalogue Number: JHJR050502J
• Device Lot Number: 15565088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2016
• 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
• Treatment: JHJR051002J/(B)(4)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR