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

Catalog Number PAJ061502

Device Problem Human-Device Interface Problem (2949)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2018

Event Type  Injury  

Manufacturer Narrative

The delivery catheter will be sent for analysis.Further information will be provided.Paj061502/16571053 (b)(4).Concomitant devices: 6fr brite tip sheath (11 cm), amplatz extra stiff wire, lundequist wire 260 cm, 4 mm x 200 mm abbott armada balloon, bern catheter, rim catheter, 180 cm glidewire, 6 mm x 200 mm abbott armada balloon, 7 mm x 120 mm zilver ptx stent, 7 mm x 100 mm zilver ptx stent.Pre-existing old zilver stent (non-eluting).

Event Description

On (b)(6) 2018 a patient was being treated for in-stent restenosis in the superficial femoral artery.A gore® viabahn® endoprosthesis with propaten bioactive surface (6 mm x 15 cm) was being utilized to reline a pre-existing zilver stent.Access was gained with a 6fr brite tip sheath, (11 cm).Wires utilized were an amplatz extra stiff wire and a lunderquest wire (260 cm).It was reported that during deployment, the gore® viabahn® endoprosthesis with propaten bioactive surface partially expanded when the deployment line snapped, leaving approximately 4 cm of the device still constrained.The delivery catheter was also stuck on the wire inside the patient¿s vessel.Numerous attempts were made to get the catheter to release.During this time, the catheter snapped, necessitating a cut-down on the patient¿s left groin in order to access and remove the broken deployment system.Because the gore® viabahn® endoprosthesis with propaten bioactive surface was partially deployed inside a zilver stent, the proximal end of the existing stent and approximately 1.5 cm of the gore® viabahn® endoprosthesis had to be cut in order to release the delivery catheter.During this process, an endarterectomy was also performed.The viabahn® catheter was cut into pieces in order to remove the lodged catheter.The delivery catheter was successfully removed along with the rest of the deployment line.The vessel was repaired.The physician proceeded to re-access the vessel under fluoroscopy and used a pta balloon to open up the damaged stents in the sfa.A portion of the expanded viabahn® device was left in place.The proximal and distal ends of the implanted devices were extended with zilver ptx stents, to overlap the damaged sections and restore flow.The final imaging revealed good distal perfusion and three vessel run-off.The patient is recovering well.Post-procedure the physician mentioned that it was possible that the wire had tracked through the pre-existing zilver stent struts, but this could not be confirmed.It was also mentioned that the patient had a very difficult initial access and the sheath length was not sufficient to reach the preexisting stent and protect the gore® viabahn® endoprosthesis with propaten bioactive surface being positioned per the gore® viabahn® endoprosthesis with propaten bioactive surface instructions for use (ifu).

Manufacturer Narrative

Two pieces of the delivery catheter were returned and appeared to be cut.The engineering observed that one piece measured approximately 15.2cm from the distal tip to the end of the distal shaft.The second piece measured approximately 97.5cm from the end of the hub to the end of the dual lumen catheter.The transition was not returned.One piece of deployment line was returned and measured approximately 11.5cm.One side of the deployment line had two single fibers that measured approximately 13.5cm.Part of the endoprosthesis was returned and measured approximately 2.8cm.Approximately 1.5cm of the proximal end of the endoprosthesis was reinforced by the nitinol wire.At 1.5cm from the proximal end, there was 1cm of nitinol wire that was not bound to the endoprosthesis.The remaining 1cm of the endoprosthesis was not lined with nitinol.The endoprosthesis was longitudinally cut.Based on the device examination performed, no manufacturing anomalies were identified.According to the gore® viabahn® endoprosthesis instructions for use (ifu) , special care should be taken to ensure that the appropriate size endoprosthesis, compatible sheath and guidewire are selected prior to introduction.Native vessel dimensions must be accurately measured, not estimated.

Manufacturer Narrative

Additional information: implant date.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7334802
• MDR Text Key: 102246985
• Report Number: 2017233-2018-00164
• 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: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2019
• Device Catalogue Number: PAJ061502
• Device Lot Number: 16571053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 98