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

Catalog Number PAJR052502E

Device Problem Activation Failure (3270)

Patient Problem Vascular Dissection (3160)

Event Date 10/01/2019

Event Type  Injury  

Manufacturer Narrative

Please be informed that within the event in total three devices were involved.They are reported with mfr report #2017233-2019-01096 (lot 20764863, partial deployment, dissection) and #2017233-2019-01097 (lot 20847702, treatment of lesion) and #2017233-2019-01098 (lot 20394918, treatment of dissection).

Event Description

The patient presented with a long complex stenosis of the right superficial femoral artery due to peripheral artery disease.It was planned to treat the lesion with a 5 mm x 25 cm gore® viabahn® endoprosthesis with propaten bioactive surface.In a cross-over maneuver using a destination® guiding sheath (terumo) the viabahn® endoprosthesis was advanced to the lesion over a 0.018¿¿ v-18¿ controlwire¿ guidewire (boston scientific).They initiated the deployment of the viabahn® endoprosthesis and pulled out the deployment line completely from the patient.Reportedly the viabahn® endoprosthesis expanded only 2 cm at the tip.The physician decided to retract the viabahn® endoprosthesis back into the introducer sheath.He managed to retract the device into the sheath except the expanded part.It was reported that the physician decided to retract the partially expanded viabahn® endoprosthesis together with the introducer sheath in a tandem from the patient.Further x-ray imaging showed that the artery got dissected.They suspected that the manipulation and the retraction of the partially expanded device might have led to this injury.To complete the procedure two viabahn® endoprostheses were placed: one viabahn® endoprostheses (6 mm x 25 cm) at the planned location, and one viabahn® endoprostheses (5 mm x 15 cm) to treat the dissection of the artery.Reportedly, x-ray imaging showed, that both viabahn® endoprostheses were not patent at the end of the intervention.The physician assumed thrombus formation due to the previous procedure.The patient received lysis for one night.The day after, the viabahn® endoprostheses were open.The patient is fine so far.

Manufacturer Narrative

D10: updated the date the device was received by the manufacturer.H6-code 213: the device was returned for investigation.The following observations.Were made: the entire device was returned.An introducer sheath was returned with the device; however, it was not evaluated as it is not a gore product.There was a 5 cm single fiber attached to the deployment knob.There was approximately 11 cm of deployment line coming off of the endoprosthesis where deployment appears to have stopped.There were two 9 cm single fibers at the end of the deployment line.Approximately 1 cm of the endoprosthesis was partially expanded near the tip end of the endoprosthesis.The endoprosthesis appeared to be damaged with stent wire delaminating from the endoprosthesis.Deployment was able to be continued with traction on the deployment line at the endoprosthesis.The remainder of the device was unremarkable.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.

Manufacturer Narrative

B5: the event description was updated based on additional information provided by the physician.The investigation results are not impacted by the updated information.

Event Description

The patient presented with a long complex in-stent stenosis of a previously implanted bare metal stent (manufacturer unknown) in the right superficial femoral artery due to peripheral artery disease.It was planned to treat the lesion with a 5 mm x 25 cm gore® viabahn® endoprosthesis with propaten bioactive surface.In a cross-over maneuver using a destination® guiding sheath (terumo) the viabahn® endoprosthesis was advanced to the lesion over a 0.018¿¿ v-18¿ controlwire¿ guidewire (boston scientific).It was reported, that it was difficult to advance the viabahn® endoprosthesis due to the stenosis.The viabahn® endoprosthesis was placed within the previously implanted bare metal stent (bms) so that it protrudes about 1 cm at each end of the bms.They initiated the deployment of the viabahn® endoprosthesis and removed the deployment line from the patient.Reportedly the viabahn® endoprosthesis expanded only 2 cm at the tip the rest of the endoprosthesis remained constrained.The physician decided to retract the viabahn® endoprosthesis back into the introducer sheath.Reportedly, he experienced big friction, but eventually he managed to retract the device into the sheath except the expanded part of the viabahn® endoprosthesis.It was reported, that the physician then retracted the partially expanded viabahn® endoprosthesis together with the introducer sheath in a tandem from the patient.Further x-ray imaging showed that the artery got dissected.They suspected that manipulation and retraction of the partially expanded device might have led to this injury.To complete the procedure two viabahn® endoprostheses were placed: one viabahn® endoprostheses (6 mm x 25 cm) at the planned location, and one viabahn® endoprostheses (5 mm x 15 cm) to treat the dissection of the artery.Reportedly, x-ray imaging showed, that both viabahn® endoprostheses were not patent at the end of the intervention.The physician assumed thrombus formation due to the previous procedure.The patient received lysis for one night.The day after, the viabahn® endoprostheses were open.The patient is fine so far.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9255195
• MDR Text Key: 164797842
• Report Number: 2017233-2019-01096
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P130006
• 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: 04/07/2020

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: 04/27/2022
• Device Catalogue Number: PAJR052502E
• Device Lot Number: 20764863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/30/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/13/2020; 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 76 YR