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

Catalog Number VBJR051502A

Device Problem Break (1069)

Patient Problems Perforation (2001); No Known Impact Or Consequence To Patient (2692)

Event Date 11/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Review of device manufacturing record history confirmed device met pre-release specifications.The returned specimen did not include the hub or deployment knob.Part of the device was inside of an introducer sheath, which was not evaluated as it is not a gore product.Approximately 10 cm of dual lumen catheter shaft was coming out of the valve-end of the introducer sheath.The hub end of the dual lumen catheter shaft appeared severed.On the opposite end, there was 9.5 cm of endoprosthesis that was partially expanded.The transition-end of the endoprosthesis appeared to be compressed/constrained within the introducer sheath.The body tape was separated from stent apices at multiple places along endoprosthesis.A loop of deployment line was coming out of the introducer sheath, with part of it looped around struts 7.5 cm from the tip-end of the endoprosthesis.No distal shaft nor distal tip could be visualized outside of the endoprosthesis.Based on the device examination performed, no manufacturing anomalies were identified.

Event Description

It was reported to gore that a patient presented for treatment in the right superficial femoral artery due to diffused peripheral disease.Pre-dilation was performed with a 3mm diameter balloon.A 6fr sheath was used to advance the gore® viabahn® endoprosthesis across the lesion and placed at the intended treatment site.Deployment was initiated, and about two-thirds of the device expanded when the deployment line broke.The catheter was cut in an attempt to locate the line remaining within the lumen.The line was not located, necessitating removal of the guidewire, sheath and the partially expanded device through the access vessel at the groin.The devices were removed, and an 11fr sheath was inserted.A new viabahn device was advanced and deployed at the treatment site.A cut down was done to repair the artery.Patient was reported to be doing well after 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: genevieve begay ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7075559
• MDR Text Key: 93493101
• Report Number: 2017233-2017-00627
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/08/2017

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: 06/12/2020
• Device Catalogue Number: VBJR051502A
• Device Lot Number: 17313027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2017
• 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: 6FR AND 11FR SHEATHS, GUIDEWIRE
• Patient Outcome(s): Required Intervention