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

Catalog Number VBJR071502A

Device Problems Premature Activation (1484); Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 11/26/2019

Event Type  malfunction  

Manufacturer Narrative

Review of the manufacturing records verified that the lot met release requirements.The investigation is ongoing.The gore® viabahn® endoprosthesis instruction for use, warnings section state: do not use a kinked introducer sheath.A kinked introducer sheath may increase the force necessary to deploy the endoprosthesis and may cause a deployment failure or catheter breakage on removal.The gore® viabahn® endoprosthesis instruction for use, directions for use section state: inflate the angioplasty balloon to its nominal pressure according to manufacturer¿s directions for use.Ensure full expansion of the balloon within the lesion.Note: carefully mark the margins of the angioplasty treatment segment in order to ensure complete coverage with the endoprosthesis.

Event Description

The following was reported to gore: the gore® viabahn® endoprosthesis was to be used in the left external iliac.The doctor elected to use an up and over approach through the very tortious calcific iliac.According to the scrub tech, when the gore® viabahn® endoprosthesis was removed from the package she observed a kink at the stent, but the doctor continued to use the device.The doctor did not predilate the vessel.The device failed to advance to the lesion so was removed.During removal the gore® viabahn® endoprosthesis partially deployed and came off the catheter.The device was removed with the sheath.

Manufacturer Narrative

Corrected data: d10.Device available for evaluation? (do not send to fda).D10.Returned to manufacturer on: h6.Results code 2.H6.Conclusions code 1.Additional manufacturer narrative: h3.Device evaluated by manufacturer? the endoprosthesis, deployment line, and delivery catheter were returned to gore and examined.Based on the 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: 9440085
• MDR Text Key: 194019302
• Report Number: 2017233-2019-01226
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00733132623785
• UDI-Public: 00733132623785
• Combination Product (y/n): N
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 01/02/2020

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: 08/12/2022
• Device Catalogue Number: VBJR071502A
• Device Lot Number: 21088547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/09/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR