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

Catalog Number VBC080502

Device Problem Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Lot/serial: (b)(4) = udi: (b)(4).The review of the manufacturing records verified that the lot met all pre-release specifications.

Event Description

It was reported to gore that the patient experienced a left limb thrombosis and the iliac artery aneurysm with aneurysm neck measuring 2cm width, a gore® viabahn® endoprothesis was to be implanted for treatment of the iliac artery aneurysm.The operation access was from the right femoral artery.After a thrombus aspiration through a 10fr cook long sheath was done, the viabahn® device was inserted and advanced over an amplatz stiff guide wire and through the 10fr cook long sheath to the target lesion.However when the viabahn® device was deployed half, a resistance was reportedly felt and the deployment was not able to continue.The partially deployed viabahn® device was able to be retracted through the 10fr long sheath out of the patient.A new device was used to continue the procedure.The patient had a good outcome post-procedure and returned back to the ward.

Manufacturer Narrative

The engineering evaluation result stated that the delivery catheter and endoprosthesis were returned.No deployment knob nor deployment line were returned.There was extra metal wiring wrapped around the endoprosthesis and delivery catheter.The extra metal wiring seemed to stem from the introducer sheath and does not appear to be of the same material as the endoprosthesis.Part of the metal wiring had clear plastic material stuck to it.The wiring and plastic are not gore products and were not evaluated.There was columnar failure of the dual lumen catheter of approximately 2.5cm in length approximately 3cm from the hub.Approximately 5.5cm of the dual lumen catheter appeared to have a smaller diameter right after the columnar failure, approximately 5.5cm from the hub.Approximately 3cm of the distal shaft, upon which the endoprosthesis is mounted, was exposed at the distal tip end.There was no distal tip attached to the distal shaft and there appears to be an interruption of the pebax where the distal tip would have been bonded and the metal portion of the distal shaft appeared frayed.The endoprosthesis was longitudinally compressed towards the transition and measured approximately 3cm.The nitinol on the endoprosthesis was not fully attached to the endoprosthesis and there were numerous outwardly facing struts.There was no evidence of inner braided constraining line on or around the endoprosthesis.Based on the device examination performed, no manufacturing anomalies were identified.

Event Description

It was reported to gore that the patient experienced a left limb thrombosis and the iliac artery aneurysm with aneurysm neck measuring 2cm width, a gore® viabahn® endoprosthesis was to be implanted for treatment of the iliac artery aneurysm.The operation access was from the right femoral artery through a 13cm cook short sheath and a 40cm 9fr cook long sheath coaxially.After a thrombus aspiration through the 40cm 9fr cook long sheath was done, the viabahn® device was inserted and advanced over an amplatz stiff guide wire and through the sheaths to the target lesion.However when the viabahn® device was deployed half, a resistance was reportedly felt and the deployment was not able to continue.The physician tried to retract the partially deployed viabahn® device through the 9fr long sheath but failed due to a strong resistance, which also caused damage to both viabahn® device and the sheaths.Therefore the physician retracted the viabahn® device out of the patient together with both sheaths.A new device and new sheath were used to continue the procedure.The patient had a good outcome post-procedure and returned back to the ward.

Manufacturer Narrative

The engineering evaluation result stated that the delivery catheter and endoprosthesis were returned.No deployment knob nor deployment line were returned.There was extra metal wiring wrapped around the endoprosthesis and delivery catheter.The extra metal wiring seemed to stem from the introducer sheath and does not appear to be of the same material as the endoprosthesis.Part of the metal wiring had clear plastic material stuck to it.The wiring and plastic are not gore products and were not evaluated.There was columnar failure of the dual lumen catheter of approximately 2.5cm in length approximately 3cm from the hub.Approximately 5.5cm of the dual lumen catheter appeared to have a smaller diameter right after the columnar failure, approximately 5.5cm from the hub.Approximately 3cm of the distal shaft, upon which the endoprosthesis is mounted, was exposed at the distal tip end.There was no distal tip attached to the distal shaft and there appears to be an interruption of the pebax where the distal tip was bonded and the metal portion of the distal shaft appeared frayed.The endoprosthesis was longitudinally compressed towards the transition and measured approximately 3cm.The nitinol on the endoprosthesis was not fully attached to the endoprosthesis and there were numerous outwardly facing struts.There was no evidence of inner braided constraining line on or around the endoprosthesis.Based on the device examination performed, no manufacturing anomalies were identified.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7532576
• MDR Text Key: 109108319
• Report Number: 2017233-2018-00293
• 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: distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/26/2020
• Device Catalogue Number: VBC080502
• Device Lot Number: 17555433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 65