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

Catalog Number JHJR081002J

Device Problem Positioning Failure (1158)

Patient Problem No Code Available (3191)

Event Date 10/25/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The following was reported to gore: on (b)(6) 2017, this patient underwent endovascular repair of the left common iliac artery occlusion (chronic total occlusion) using non-gore device.During the procedure, an iatrogenic cia injury was confirmed, and it was elected to implant a gore® viabahn® endoprosthesis to repair the injury.During deployment of the endoprosthesis, around 3cm of the endoprosthesis was unintentionally deployed inside a 7fr short sheath as the sheath was reportedly not withdrawn enough.It was tried to withdraw only the sheath to completely implant the endoprosthesis at that place.However, the endoprosthesis inside the sheath was stuck together with the sheath, and the attempt was reportedly unsuccessful.The whole endoprosthesis and the sheath were withdrawn to a puncture site.Cut down was performed and the endoprosthesis was exposed from the cut down site.The endoprosthesis inside the sheath was intentionally cut off from the rest of the endoprosthesis.The rest of the endoprosthesis was returned to the artery from the cut down site, and two bare metal stents were implanted to reline the endoprosthesis.The procedure was concluded, and the patient tolerated the procedure.

Manufacturer Narrative

(b)(4).

• 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: saori kawai ; 9285263030
• MDR Report Key: 7047859
• MDR Text Key: 92593788
• Report Number: 2017233-2017-00615
• 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,Followup,Followup
• Report Date: 03/05/2018

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: 10/11/2019
• Device Catalogue Number: JHJR081002J
• Device Lot Number: 15775681
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/21/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/27/2017; 03/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2016
• 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
• Patient Outcome(s): Other