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

Model Number VBJR051502A

Device Problem Device Damaged by Another Device (2915)

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

Event Date 02/13/2020

Event Type  malfunction  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.

Event Description

On (b)(6) 2020, the patient underwent treatment of percutaneous deep vein arterialization in the posterior tibial artery using gore® viabahn® endoprostheses (viabahn) and a resolute onyx medtronic balloon expandable drug eluting stent.It was reported the physician deployed the 4mm x 38mm resolute onyx medtronic balloon expandable drug eluting stent in the posterior tibial artery.The physician then unsuccessfully attempted to introduce a (5x25) viabahn multiple times.The physician was unable to track the device across the previously implanted balloon expandable stent (onyx), due to the tight nature of the junction.The physician post dilated the onyx with both 3mm and 5mm balloons.It was reported the vbx successfully tracked and deployed into the posterior tibial vein.The physician then successfully advanced a (5x15) viabahn through the existing (5x25) viabahn and onyx device to extend off of the previously implanted viabahn.During deployment of the (5x15) viabahn the deployment knob was pulled and only a portion of the deployment line came out of the hub, leaving the device partially constrained.It was reported the deployment line broke at the end of the catheter inside of the patient.The physician attempted to retrieve the remaining deployment line by cutting the catheter.However, the physician was unable to retrieve the remaining deployment line with surgical clamps.It was reported while the physician attempted to retrieve deployment line of the (5x15) viabahn was moved separating it from the onyx device.The physician introduced a coronary balloon into the deployed portion of the (5x15) viabahn.The physician then inflated the balloon while another physician pulled from above on the deployment catheter.The viabahn was fully deployed, however, the device deployed approximately 2cms proximal from its intended landing zone.It was reported a (5x10) viabahn was successfully advanced and deployed to bridge the two previous vsxs.The procedure was completed successfully.The physician stated the suspected cause of the deployment line breaking was the angled profile of the previously implanted onyx device as well as the device's sharp struts.

Event Description

On (b)(6) 2020, the patient underwent treatment of percutaneous deep vein arterialization in the posterior tibial artery using a resolute onyx medtronic balloon expandable drug eluting stent and three gore® viabahn® endoprostheses (viabahn device).It was reported the 4mm x 38mm resolute onyx medtronic balloon expandable drug eluting stent was deployed in the posterior tibial artery.The physician made several attempts to advance the first viabahn (5x25) device, but device was unable to track across the implanted onyx stent due to the tight nature of the junction.The onyx stent was post dilated with both 3mm and 5mm balloons.The same (5x25) viabahn device successfully tracked and was deployed into the posterior tibial vein.For extension of the first viabahn device, a (5x15) viabahn device was advanced through the onyx stent and the (5x25) viabahn device.During deployment of the (5x15) viabahn device the deployment knob was pulled and only a portion of the deployment line came out of the hub, leaving the device partially constrained.It was reported the deployment line broke at the end of the catheter inside of the patient.The catheter was cut in order to retrieve the remaining deployment line.However, the physician was unable to retrieve the remaining deployment line with surgical clamps.During attempts to retrieve deployment line, the (5x15) viabahn device was moved, disconnecting it from the onyx stent.The physician inserted a coronary balloon into the deployed portion of the (5x15) viabahn device.The balloon was inflated and another physician pulled from above on the deployment catheter.The viabahn device was fully expanded 2 cm proximal from its intended landing zone.A (5x10) viabahn device was advanced and deployed to bridge the two disconnected devices.The procedure was completed with no harm to the patient.The physician stated the suspected cause of the deployment line breaking was the angled profile of the implanted onyx stent with sharp struts.

Manufacturer Narrative

Corrected event description.Instructions for use for gore® viabahn® endoprosthesis with heparin bioactive surface state in warnings section: w.L.Gore & associates has insufficient clinical and experimental data upon which to base any conclusions regarding the effectiveness of the gore® viabahn® endoprosthesis in applications where the device is deployed within stents or stent grafts other than the gore® viabahn® endoprosthesis.Other devices may interfere with the deployment of the gore® viabahn® endoprosthesis resulting in deployment failure or other device malfunction.

Manufacturer Narrative

Code 10 - refer to the device evaluation summary below for the results of the engineering evaluation.Code 213 ¿ the review of the manufacturing paperwork verified that this lot met all pre-release specifications.Code 4315 - as the device was not returned, no evaluation of the device could be performed.Engineering evaluation task was performed and the results are: device 5mm x 15cm: no devices or images were returned for evaluation; therefore, no physical evaluation of the device can be performed.No anomalies or non-routine maintenance were identified that could be attributed to the failure seen in this event.Therefore, based off of the evaluation performed, no manufacturing cause could be identified.Engineering evaluation conclusion is inconclusive as it relates to the event description.

Manufacturer Narrative

Corrected h6: method code 2 4114.Engineering evaluation task was performed and the results are: device 5mm x 15cm: no devices or images were returned for evaluation; therefore, no physical evaluation of the device can be performed.No anomalies or non-routine maintenance were identified that could be attributed to the failure seen in this event.Therefore, based off of the evaluation performed, no manufacturing cause could be identified.Engineering evaluation conclusion is inconclusive as it relates to the event description.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9800248
• MDR Text Key: 197833157
• Report Number: 2017233-2020-00152
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00733132623921
• UDI-Public: 00733132623921
• 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,Followup
• Report Date: 04/21/2020

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: 05/21/2021
• Device Model Number: VBJR051502A
• Device Catalogue Number: VBJR051502A
• Device Lot Number: 18353172
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/31/2020; 04/17/2020; 04/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR