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

Catalog Number JHJR052502J

Device Problem Material Integrity Problem (2978)

Patient Problem No Code Available (3191)

Event Date 02/04/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation involved the analysis of images provided by the physician.Evaluation results: angiographic image dated (b)(6) 2020 illustrates what appears to be a total occlusion of the sfa.Angiographic image dated (b)(6) 2020 illustrating that the proximal aspect of the endoprosthesis appears to be constrained while the distal aspect of the device appears to be deployed.Angiographic image dated (b)(6) 2020 illustrating that the proximal aspect of the endoprosthesis appears to be deployed.Angiographic image dated (b)(6) 2020 illustrates that the sfa appears.(b)(4).

Event Description

On (b)(6) 2020, the patient underwent an endovascular treatment for occlusion and stenosis of the right superficial femoral artery using gore® viabahn® endoprosthesis with heparin bioactive surface.Pre-ballooning was performed, and an attempt was made to advance the delivery catheter.Reportedly, resistance was felt and the delivery catheter would not advance, the delivery catheter was withdrawn from the patient.Pre-ballooning was performed again, and the delivery catheter was advanced to the intended position.During the deployment of the endoprosthesis, the deployment line was broken.It was noted approximately 10 cm of the endoprosthesis remained constrained.The delivery catheter was cut to find the remaining deployment line, and the line was pulled.The deployment of the endoprosthesis continued a little, however, the line was broken again.A cut down was performed around the position of the endoprosthesis to find the remaining deployment line, and the line was pulled again.The reminder of the endoprosthesis was fully deployed.It was reported that no fragments of the deployment line remained in the patient.Another gore® viabahn® endoprosthesis with heparin bioactive surface was then deployed as planned, and the procedure was completed.The patient tolerated the procedure.The physician reportedly stated as the catheter was being advance resistance was met.The device was forcefully pushed and the device was able to be advanced.It is suspected the deployment line might have been damaged while the device was being forcefully advanced.The physician also mentioned calcification may have affected to the device.However, intra-procedural imaging did not confirm the cause.

Manufacturer Narrative

Corrected the conclusion code.The device was returned to w.L.Gore & associates for engineering investigation.The following observations were made: the delivery catheter, deployment line, deployment knob, introducer sheath, guidewire, and tuohy borst adapter were returned.The introducer sheath, guidewire, and tuohy borst adapter were not evaluated as they were not gore products.The deployment line appeared to be broken and was returned in four separate sections.The first section was still attached to the deployment knob at measured 182.7cm including two single fibers on the end 19.5cm and 0.3cm in length.The second section measured 51.2cm including three single fibers on one end 14.2cm, 0.5, 0.3cm cm in length.Additionally, two single fibers measuring 19cm and 76.5cm were returned.The delivery catheter appeared to be cut and resulted in two sections.One section was still attached to the hub and measured 77cm.The other section measured 49.5cm and included the distal shaft and distal tip.There was a 2.3cm longitudinal cut in the dual lumen.There was a kink in the distal shaft, upon which the endoprosthesis was mounted, at the transition.Based on the evaluation performed, no manufacturing anomalies were identified to which the event could be definitively attributed.Engineering evaluation conclusion is: deployment line broken.

Manufacturer Narrative

H6: the device was returned to w.L.Gore & associates for investigation.Additionally, two photos were returned and evaluated for the investigation.The following observations were made: the delivery catheter, deployment line, deployment knob, introducer sheath, guidewire, and tuohy borst adapter were returned.The introducer sheath, guidewire, and tuohy borst adapter were not evaluated as they were not gore products.The deployment line appeared to be broken and was returned in four separate sections.The first section was still attached to the deployment knob at measured 182.7cm including two single fibers on the end 19.5cm and 0.3cm in length.The second section measured 51.2cm including three single fibers on one end 14.2cm, 0.5, 0.3cm cm in length.Additionally, two single fibers measuring 19cm and 76.5cm were returned.The delivery catheter appeared to be cut and resulted in two sections.One section was still attached to the hub and measured 77cm.The other section measured 49.5cm and included the distal shaft and distal tip.There was a 2.3cm longitudinal cut in the dual lumen.There was a kink in the distal shaft, upon which the endoprosthesis was mounted, at the transition.Based on the evaluation performed, no manufacturing anomalies were identified to which the event could be definitively attributed.Engineering evaluation conclusion is: deployment line broken.

Manufacturer Narrative

The investigation involved the analysis of images provided by the physician.Evaluation results: angiographic image dated (b)(6) 2020 illustrates what appears to be a total occlusion of the sfa.Angiographic image dated (b)(6) 2020 illustrating that the proximal aspect of the endoprosthesis appears to be constrained while the distal aspect of the device appears to be deployed.Angiographic image dated (b)(6) 2020 illustrating that the proximal aspect of the endoprosthesis appears to be deployed.Angiographic image dated (b)(6) 2020 illustrates that the sfa appears to be patent.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9775227
• MDR Text Key: 190471889
• Report Number: 2017233-2020-00137
• 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,Followup
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2022
• Device Catalogue Number: JHJR052502J
• Device Lot Number: 21365339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/02/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/05/2020; 03/16/2020; 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR