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

Catalog Number PAJR060502E

Device Problem Activation Failure (3270)

Patient Problem Death (1802)

Event Date 09/30/2019

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.The investigation involved the analysis of images provided by the physician.Evaluation results: images provided are procedural angiograms dated (b)(6) 2019.Unable to identify right renal artery endoleak with available image set.The device was returned for investigation, which is ongoing.

Event Description

It was reported that during an aortic aneurysm repair gore® viabahn® endoprostheses with propaten bioactive surface were intended to be used as a chimney devices to maintain further blood flow to the renal arteries.Access was gained via the left brachial artery.Procedure right renal artery: a short 7fr introducer sheath was placed.A catheter of type ¿headhunter¿ was used as a pathfinder to the right renal artery.A 6mm x 10cm viabahn® endoprosthesis was advance over a 0.035¿¿ guidewire and successfully deployed in the right renal artery.Reportedly the final control x-rays of the procedure showed that the right renal artery was perfused properly.Imaging also showed a minimal endoleak in the region of this viabahn® endoprosthesis.A reintervention due to the endoleak was not required.Procedure left renal artery: a 6fr steerable guiding sheath (oscor) was used as a pathfinder to the left renal artery.A 6mm viabahn® endoprosthesis was advanced over a 0.018¿¿ guidewire to the left renal artery to the intended location.The physician started the deployment of the viabahn® endoprosthesis by pulling the deployment knob.Reportedly, the viabahn® endoprosthesis showed a ¿bow-string¿ effect and would not start to expand.It was suspected that this viabahn® endoprosthesis failed to deploy due to a material defect.Therefore the physician decided to retract the viabahn® endoprosthesis through the introducer sheath to withdraw it from the patient.Subsequently the deployment line got caught in the struts of the main body of the aortic endoprosthesis.When pulling the viabahn® endoprosthesis towards the brachial access also the main body moved proximal.Another physician assisted at the groin-access for the main body to keep it at the intended position while the responsible physician made further attempts to retract the viabahn® endoprosthesis.Eventually they broke the deployment line intentionally to be able to withdraw the viabahn® endoprosthesis.Then they managed to retract the viabahn® endoprosthesis through the introducer sheath from the patient.After this event they opted for a 6mm viabahn® endoprosthesis designed to be used with a 0.035¿¿ guidewire.They replaced the guidewire and started to advance the new viabahn® endoprosthesis.It was stated that they failed to advance the device through the 6fr steerable guiding sheath (oscor), because the diameter of the viabahn® endoprosthesis was too big.It was stated that after this event they replaced the 0.035¿¿ guidewire by another 0.018¿¿ guidewire and used another 6mm viabahn® endoprosthesis designed to be used with a 0.018¿¿ guidewire to not loose the brachial access.This viabahn® endoprosthesis was advanced to the left renal artery and deployed successfully.It was stated that the final control x-rays showed that the left renal artery was perfused properly.It was reported that later on an injury of the left kidney was suspected.It was stated that the injury has occurred during advancement of the other 0.018'' guidewire.It was stated that the injury was not diagnosed in a timely manner.Subsequently the patient passed away.

Manufacturer Narrative

Outcomes attributed to adverse event: several attempts were made to obtain the date of death.The information was not provided.Several attempts were made to obtain the brand names and manufacturers of the concomittant devices.The information was not provided.Code-213: the entire device was returned for investiagtion.The following observations were made: there was approximately 13 cm of deployment line between the deployment knob and the hub.The outer braided constraining line was deployed to the tip end of the device.The endoprosthesis was still constrained.The endoprosthesis appeared to be curved and bowstrung.Deployment was able to be continued with traction on the deployment line at the endoprosthesis.The remainder of the device was unremarkable.Engineering evaluation conclusion(s) are: ¿bowstringing¿ or curved endoprosthesis due to deployment line tension.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.

Manufacturer Narrative

An additional gore® viabahn® endoprosthesis was used during attempts to treat the left renal artery during same procedure.In a conservative approach, device lot #20835036 was selected for reporting purposes.With available information we were unable to determine which device(s) may have contributed to the adverse event.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9355265
• MDR Text Key: 167387731
• Report Number: 2017233-2019-01167
• 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: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2022
• Device Catalogue Number: PAJR060502E
• Device Lot Number: 20835036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 86 YR
• Patient Weight: 68