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

Catalog Number JHJR080502J

Device Problem Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2020

Event Type  malfunction  

Event Description

The following was reported to gore: on (b)(6) 2020, the patient underwent endovascular treatment of a thoraco-abdominal aortic dissection with re-entry tear of the left renal artery.A gore® viabahn® endoprosthesis (8mm x 5cm) was delivered to the intended position and the deployment line was pulled.When the stent graft was expanded approximately 5mm, the deployment line stuck.The partially expanded gore® viabahn® endoprosthesis (8mm x 5cm) was removed.Another gore® viabahn® endoprosthesis (7mm x 5cm) was used as replacement and it was deployed successfully.The physician suggested the following: the cause of the partial deployment of the gore® viabahn® endoprosthesis was the deployment line became stuck due to bowstringing.

Manufacturer Narrative

Results code 1: 213: a review of the manufacturing records for the device verified the lot met all pre-release specifications.

Manufacturer Narrative

Additional manufacturing narrative: c1.Name (#1) - cbas® heparin surface; manufacturer/compounder: w.L.Gore & associates, inc.Lot #20967222.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Manufacturer Narrative

Corrected data: h6.- method code 2; h6.- results code 2; h6.- conclusions code 1.Additional manufacturer narrative: examination of the returned gore® viabahn® endoprosthesis revealed the following: the entire device was returned; there was approximately 17.6cm of deployment line between the hub and deployment knob; there was a kink in the distal shaft, upon which the endoprosthesis is mounted, at the transition; approximately 0.4cm of the endoprosthesis was expanded; the remainder of the endoprosthesis was constrained by the inner braided constraining line; bowstringing of the endoprosthesis was observed due to tension on the deployment line; deployment was able to be continued with traction on the deployment line at the endoprosthesis.Based on the evaluation 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: 9960507
• MDR Text Key: 188394133
• Report Number: 2017233-2020-00250
• 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,Followup
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2022
• Device Catalogue Number: JHJR080502J
• Device Lot Number: 20967222
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/14/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 05/11/2020; 07/03/2020; 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR