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

Model Number VBC060502

Device Problems Migration or Expulsion of Device (1395); Activation Problem (4042)

Patient Problem Perforation (2001)

Event Date 04/30/2020

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records indicated the device met pre-release specifications.The device was waiting to be returned.The images received cannot be used to perform a full imaging evaluation.The extent and accuracy of the observations and findings may be limited due to the completeness, format and/or quality of the available images provided for review.Gore cannot make conclusions or guarantee the images provided are accurate or lack alteration.Therefore, gore cannot guarantee all key findings have been captured or that the findings are accurate.Summary was made by imaging associate: the images received do not have any patient identifiers.The images provided are 2.Jpg¿s and 5 video files.The device appears to be partially deployed, with the distal end of the device still constrained.On video file number 5, the partially constrained device appears to be pulled in an attempt to remove the device.In this video, there appears to be 2 devices that are overlapped.

Event Description

The following was reported to gore: on (b)(6) 2020, a patient was to be implanted with a 6mm x 5cm gore® viabahn® endoprosthesis to treat left superficial femoral artery restenosis.The patient was previously implanted with a bare metal stent(bms) in the distal of left superficial femoral artery.Now the original stent was broken and in stent restenosis(isr) was found.The viabahn device was advanced via the sheath from the right femoral artery to the target lesion, and was dilated with 5mm balloon.The physician initiated and pulled out the deployment line successfully.However, the distal of the viabahn device couldn't expand.The viabahn device migrated when the delivery system was removed.The situation couldn't be solved after waiting for 5 minutes.The physician tried to advance another 8fr sheath via the guidewire into the viabahn device, but couldn't make it.After that the physician decided to perform a surgical intervention from left popliteal artery to remove the viabahn device, and the procedure was completed.The patient tolerated the procedure and stayed at hospital extending for one more day.Inspecting the viabahn device after procedure, the distal viabahn device still constrained.

Manufacturer Narrative

H6: code1 213: the device was returned to w.L.Gore & associates for investigation.Four images and five videos were returned.The clinical imaging did not assist in the engineering evaluation of the device.The following observations were made by engineer, refer to the images below: the endoprosthesis, delivery catheter, tuohy borst cap, and an unidentifiable polymer sleeve were returned.The tuohy borst cap and the polymer sleeve were not evaluated as these are not gore products.The polymer material is not consistent with materials used in viabahn manufacturing.There were kinks in the dual lumen approximately 2cm, 55.5cm, 76.2cm,97cm, and 104.3cm from the hub.The delivery catheter appeared to be cut and resulted in two sections.One section was still attached to the hub and measured 111.4cm.The other section measured 14cm including the distal tip.There were kinks in the distal shaft, upon which the endoprosthesis was mounted, approximately 0.4cm, 2.2cm, and 3.4cm from the distal tip.Approximately 3.6cm of the scalloped end of the endoprosthesis was expanded.Approximately 1.4cm of the endoprosthesis remained within the polymer sleeve.There was 1.5cm of polymer sleeve extended beyond the straight cut end of 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: 10064467
• MDR Text Key: 193301348
• Report Number: 2017233-2020-00368
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00733132614448
• UDI-Public: 00733132614448
• 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
• Report Date: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2021
• Device Model Number: VBC060502
• Device Catalogue Number: VBC060502
• Device Lot Number: 20864975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2020
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Weight: 60