MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number JHJR062502J

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Unspecified Infection (1930); Pain (1994)

Event Date 12/03/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2016, the patient underwent an endovascular procedure using two gore® viabahn® endoprostheses to repair occlusion of the left superficial femoral artery.The patient tolerated the procedure.On (b)(6) 2016, it was reported that there was an edema proximal to the endoprosthesis and the patient developed fever.The physician suspected an infection, and an antibiotic was started.After that, c-reactive protein was decreased but fever was not decreased enough.At the end of (b)(6) 2016, steroid was administered, and fever was then decreased.Reportedly, causal bacterium was unknown, the patient had no comorbidity which might be related to the event, and the physician considered it was unknown whether the endoprosthesis contributed to the event.

Manufacturer Narrative

(b)(4).The review of the manufacturing and sterilization paperwork verified that the lots met all pre-release specifications.

Event Description

On or about (b)(6) 2016, the patient presented to the hospital and complained a leg pain.Fever was over 40 degrees celsius.Swelling was observed around the location of jhjr070502j/15539364.The physician suspected an infection, and antibiotics was continuously administered after the hospital visit.However, the patient's fever continued to go up and down between 37-39 degrees celsius until the 21st day from the visit.So steroids was administered on the 21st day, and fever was resolved on the 22nd day.Reportedly, computed tomography (ct) which maybe performed in (b)(6) 2016 showed something like an abscess around jhjr070502j/15539364.The physician now suspects that it was an inflammatory reaction rather than an infection.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• 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: saori kawai ; 9285263030
• MDR Report Key: 6259327
• MDR Text Key: 65028180
• Report Number: 2017233-2017-00025
• Device Sequence Number: 1
• Product Code: NIP
• 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,Followup,Followup
• Report Date: 02/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2018
• Device Catalogue Number: JHJR062502J
• Device Lot Number: 14857936
• 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: 09/30/2015
• 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