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

Catalog Number JHJR051502J

Device Problems Positioning Failure (1158); Difficult or Delayed Activation (2577)

Patient Problem Occlusion (1984)

Event Date 06/21/2018

Event Type  Injury  

Manufacturer Narrative

The gore® viabahn® endoprosthesis with heparin bioactive surface instructions for use (ifu) states, ¿once deployment has started, repositioning of the endoprosthesis should not be attempted.¿.

Event Description

On (b)(6) 2018, this patient underwent an endovascular repair for an occlusion of the left superficial femoral artery using gore® viabahn® endoprosthesis with heparin bioactive surface.Access was gained from the left common femoral artery with a 6fr sheath.After pre-ballooning was performed, the first endoprosthesis (5 mm x 25 cm) was implanted.The second endoprosthesis (5 mm x 15 cm) was intended to be implanted proximal to the first endoprosthesis.After the deployment was started, the patient reportedly showed body motion, reportedly due to pain.It was reported that some resistance was felt during the deployment.The deployment was continued, however the deployment line reportedly broke and the device was partially expanded.As the line was broken and the endoprosthesis was partially expanded, the physician was unable to withdraw the delivery catheter.Therefore, the physician moved the catheter several times.When the physician pulled the delivery catheter with some force, the expansion of the endoprosthesis was re-started and the device was completely deployed.At this point the delivery catheter was able to be withdrawn from the patient.It was reported that the broken deployment line was also withdrawn.As the left superficial femoral artery was covered by the endoprosthesis, an attempt was made to withdraw the endoprosthesis post deployment.However, this was unsuccessful, and the patient was transferred to another hospital for a surgical repair on the same day.

Manufacturer Narrative

Additional manufacturer narrative/corrected data - engineering evaluation: the following observations were made: the deployment line, deployment knob, delivery catheter, and an introducer sheath were returned.The introducer sheath was not evaluated because it is not a gore device.No endoprosthesis was returned.The deployment line was broken and returned in in two pieces.The first piece was connected to the deployment knob and measured 156 cm and the second piece measured 22 cm with two long single fibers coming off of the end of the second piece.The remainder of the device is unremarkable.Engineering evaluation conclusion(s) are: deployment line broken.Based on the device examination performed, no manufacturing anomalies were identified.

Manufacturer Narrative

Additional manufacturer narrative/corrected data - method code 2.Results code 2.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7699798
• MDR Text Key: 114356227
• Report Number: 2017233-2018-00381
• 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: 08/31/2018

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: 11/26/2020
• Device Catalogue Number: JHJR051502J
• Device Lot Number: 17623505
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/18/2018
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/27/2018; 08/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 69 YR