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

Catalog Number PAHR080502E

Device Problems Partial Blockage (1065); Activation, Positioning or Separation Problem (2906); Difficult to Advance (2920); Material Deformation (2976); Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)

Patient Problems Occlusion (1984); Obstruction/Occlusion (2422)

Event Date 12/03/2018

Event Type  Injury  

Event Description

The patient presented with an aneurysm within the internal iliac artery which was intended to be treated with a gore® viabahn® endoprosthesis in combination with a gore® excluder® iliac branch endoprosthesis.It was reported to gore that difficulties were experienced while the medical device was advanced to the target lesion.It was stated that a x-ray of the gore® viabahn® endoprosthesis revealed that the proximal marker of the viabahn device had an ¿o¿ shape instead of a dot.It was stated that a kink in the catheter shaft might have caused the ¿o¿ shape.Therefore the guidewire was exchanged to a stiff wire and the medical device was slightly pulled back which lead to a disappearing of the ¿o¿ shape.Reportedly, the device was on the right target lesion and device deployment was initiated.It was reported that the catheter of the device molded a bow string during deployment and it was stated that 0,5mm of the distal portion of the endoprosthesis couldn¿t be deployed.Consequently, a balloon was used with the attempt to force deployment of the undeployed portion of the endoprosthesis which wasn¿t successful.When the delivery catheter was tried to be pulled back from the patient¿s vessel some resistance was experienced which led in a temporary movement of the deployed endoprosthesis of about 2cm as force was used during device removal.The final angiography indicated that the gore® viabahn® endoprosthesis was implanted on the target lesion, with an undeployed distal portion of 0,5mm, which led to an occlusion of the internal iliac artery.It was stated that the patient was doing well following the procedure.

Manufacturer Narrative

A review of the manufacturing records for the device verified that the lot met all pre-release specifications.

Manufacturer Narrative

The following codes were added to section h6: result code: 3243, 3207.Conclusion code: 4315.Engineering evaluation: the delivery catheter was returned with a white non-gore knob attached to the hub where the deployment knob would be.No endoprosthesis was returned.No deployment knob or deployment line were returned.All returned components, including the dual lumen and distal shaft, were unremarkable.Based on the device examination performed, no manufacturing anomalies were identified.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8207581
• MDR Text Key: 131762090
• Report Number: 2017233-2018-00791
• 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: 02/08/2019

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: 08/04/2021
• Device Catalogue Number: PAHR080502E
• Device Lot Number: 18709580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/02/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/25/2019; 02/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability