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

Model Number VBC101502

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 02/14/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing records indicated the device met pre-release specifications.The imaging could not be performed as the images were not available.The device was waiting to be returned.Warnings section in ifu states: do not withdraw the gore® viabahn® endoprosthesis back into the introducer sheath once the endoprosthesis is fully introduced.Withdrawing the gore® viabahn® endoprosthesis back into the sheath can cause damage to the endoprosthesis, premature deployment, deployment failure, and/or catheter separation.If removal prior to deployment is necessary, withdraw the gore® viabahn® endoprosthesis to a position close to but not into the introducer sheath.Both the gore® viabahn® endoprosthesis and introducer sheath can then be removed in tandem.After removal, do not reuse the gore® viabahn® endoprosthesis or introducer sheath.

Event Description

The following was reported to gore: on (b)(6) 2020, a patient was to be implanted with a 10mm x 15cm gore® viabahn® endoprosthesis to treat common iliac aneurysm.It was reported thrombolysis were firstly performed.After that the common iliac artery was noted in good condition without tortuosity and calcification.After the viabahn device was advanced via 12fr sheath to the target lesion, the physician initiated the deployment line, no resistance was reportedly felt.However, the deployment line got stuck when the viabahn® device expanded 1/3.The viabahn® device couldn't be deployed after many attempts.The physician decided to withdraw the viabahn device back into the sheath but couldn't make it.Then the viabahn device and sheath were removed in tandem with great efforts.During the removal, the endoprosthesis was totally expanded and damaged.It was difficult and took a long to withdraw the viabahn device.A vbh111002w (11mm x 10cm), a vbc110502 (11mm x 5cm) and a vbc100202(10mm x 5cm) were used to complete the procedure successfully.The patient tolerated the procedure.

Manufacturer Narrative

Update event description.Code1 213 - the images were not available, the imaging evaluation could not be performed.The device was returned and the engineering evaluation was performed on the device.The following observations were made by engineer: the entire device was returned except for the distal tip.The deployment line was taut within the hub.There was approximately 111 cm of deployment line coming out of the transition with a 0.5 cm single fiber on the end of the deployment line.The distal shaft, upon which the endoprosthesis was mounted, was damaged where the tip would have been located and the stainless steel braid of the distal shaft was exposed, see.The endoprosthesis was fully expanded and damaged.There was delamination 5 cm from the scalloped cut end of the endoprosthesis that was about 2 cm long and a second section of delamination about 9.5 cm from the scalloped cut end of the endoprosthesis that was about 1 cm long.Based on the evaluation performed, no manufacturing anomalies were identified to which the event could be definitively attributed.Warnings section in ifu states: do not withdraw the gore® viabahn® endoprosthesis back into the introducer sheath once the endoprosthesis is fully introduced.Withdrawing the gore® viabahn® endoprosthesis back into the sheath can cause damage to the endoprosthesis, premature deployment, deployment failure, and / or catheter separation.If removal prior to deployment is necessary, withdraw the gore® viabahn® endoprosthesis to a position close to but not into the introducer sheath.Both the gore® viabahn® endoprosthesis and introducer sheath can then be removed in tandem.After removal, do not reuse the gore® viabahn® endoprosthesis or introducer sheath.

Event Description

The following was reported to gore: on (b)(6) 2020, a patient was to be implanted with a 10mm x 15cm gore® viabahn® endoprosthesis to treat common iliac aneurysm.It was reported thrombolysis were firstly performed.After that the common iliac artery was noted in good condition without tortuosity and calcification.After the viabahn device was advanced via 12fr sheath to the target lesion, the physician initiated the deployment line, no resistance was reportedly felt.However, the deployment line got stuck when the viabahn® device expanded 1/3.The viabahn® device couldn't be deployed after many attempts.The physician decided to withdraw the viabahn device back into the sheath but couldn't make it.Then the viabahn device and sheath were removed in tandem with great efforts.During the removal, the endoprosthesis was totally expanded and damaged.It was difficult and took a long to withdraw the viabahn device.A vbh111002w (11mm x 10cm), a vbc110502 (11mm x 5cm) and a vbc100502(10mm x 5cm) were used to complete the procedure successfully.The patient tolerated the procedure.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9760771
• MDR Text Key: 197836502
• Report Number: 2017233-2020-00131
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00733132614691
• UDI-Public: 00733132614691
• 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: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/11/2021
• Device Model Number: VBC101502
• Device Catalogue Number: VBC101502
• Device Lot Number: 18766435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 62