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

Catalog Number JHJR051502J

Device Problems Activation Failure (3270); Premature Separation (4045)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/18/2019

Event Type  malfunction  

Event Description

Following was reported to gore.On (b)(6) 2019, a patient underwent a treatment of isr and significantly calcified lesion in the right superficial femoral artery with two gore® viabahn® endoprosthesis with heparin bioactive surface.A jhjr051502j was placed first followed by a jhjr052502j.The jhjr051502j was advanced to the intended position with no reported issues.Upon initiating deployment, the deployment line broke, and became separated before the device fully expanded.The physician cut the delivery catheter at the hub, but the broken deployment line was not found within the catheter lumen.A 6fr sheath was advanced for attempting to fully expand the device using the sheath tip, and the attempt succeeded.The procedure was completed without any adverse event.The device will be returned to us for evaluation.A customer response letter is required.The fsa requested that the description of possible event that occurred from the condition of returned broken deployment line length, and/or deployment line cut surface will be included into the customer letter.

Manufacturer Narrative

H.6.Results code 1: 213: a review of the manufacturing records for the device verified the lot met all pre-release specifications.H.6.Results code 2: 213: the engineering evaluation stated the following: the following observations were made: the deployment line, deployment knob, and delivery catheter were returned.There was no hub attached to the delivery catheter.There was approximately 139 cm of deployment line attached to the deployment knob with an 11 cm single fiber coming from the end of the deployment line.There was approximately 119 cm of delivery catheter returned including the distal shaft, upon which the endoprosthesis was mounted, and the distal tip.The dual lumen was cut down the middle for 70 cm from the hub end of the dual lumen.The radiopaque marker band from the distal tip was displaced and located on the distal shaft.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9526050
• MDR Text Key: 213396024
• Report Number: 2017233-2019-01278
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2020
• Device Catalogue Number: JHJR051502J
• Device Lot Number: 16538964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1