MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number VBJR070502A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Ruptured Aneurysm (4436)

Event Date 03/31/2023

Event Type  Death  

Event Description

The following information was provided to gore: on (b)(6) 2023, a gore® viabahn® endoprosthesis (vsx device) was intended for use in the splenic artery for treatment of a preexisting rupture.From a right common femoral artery approach, the vsx devise was advance across the aneurysm.The physician then attempted to deploy the vsx device.However, the vsx device started to bowstring and would not continue deploying.The physician made several attempts to continue deployment with no success.With no device expansion, the physician then attempted to remove the vsx device through the introducer sheath (manufacturer unknown) with no success.The decision was made to remove the deployment system and introducer sheath in tandem.However, the proximal end of the vsx device got hung up at the access site.The physician attempted to manipulate the device for removal, when the delivery catheter broke.There was still wire access to the artery and the retained fragment of the delivery system, and the retained stent graft were on the wire in the common femoral artery (still not deployed and completely collapsed other than the most proximal portion of the stent graft).The sheath and the shaft of the delivery system were outside of the patient, but the deployment string remained attached to the internal fragment and the external fragment.The physician then got left common femoral artery access, placed a sheath up and over into the right side, and attempted to retrieve the stent.Before they could snare the stent, the distal end of the stent finally began to deploy, which made any attempts to percutaneously remove the stent futile.During this process, the retained distal fragment of the deployment system was captured with the snare, but it could not be withdrawn into the sheath.Once both femoral artery accesses were occupied and no longer available to re-attempt the splenic artery aneurysm repair, the situation was discussed with the general surgeon and vascular surgeon on call.The patient then went to the or for emergent surgical exploration.Due to being in critical condition requiring vasopressors, no attempt could be made to remove the covered stent given the instability of the patient.The patient was taken back to the sicu and expired.

Manufacturer Narrative

Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

Section h6 updated to reflect completion of investigation.The manufacturing records were reviewed and documented in the product history task.The device lot met all pre-release specifications.No information about the device availability.Consequently, a direct product analysis was not possible.The cause for the reported deployment failure and bow-stringing could not be independently confirmed because neither images nor the device itself were returned for evaluation.The investigation could not confirm the cause of the reported primary hazardous situation nor the primary device failure mode.The investigation of this complaint identified the following hazardous situations: unable to use device after insertion (primary) and unplanned addition/removal of accessories (secondary).Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.The following ifu statements were identified in relation to this complaint: do not withdraw the gore® viabahn® endoprosthesis with heparin bioactive surface back into the introducer sheath once the endoprosthesis is fully introduced.Withdrawing the gore® viabahn® endoprosthesis with heparin bioactive surface back into the sheath can cause damage to the endoprosthesis, premature deployment, deployment failure, and/or catheter separation.If removal prior to deployment is necessary, withdraw the gore® viabahn® endoprosthesis with heparin bioactive surface to a position close to but not into the introducer sheath.Both the gore® viabahn® endoprosthesis with heparin bioactive surface and introducer sheath can then be removed in tandem.After removal, do not reuse the gore® viabahn® endoprosthesis with heparin bioactive surface or introducer sheath.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16796645
• MDR Text Key: 313837585
• Report Number: 2017233-2023-03880
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00733132623761
• UDI-Public: 00733132623761
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2023

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 Model Number: VBJR070502A
• Device Catalogue Number: VBJR070502A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2023
• Initial Date FDA Received: 04/24/2023
• Supplement Dates Manufacturer Received: 05/31/2023
• Supplement Dates FDA Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Death
• Patient Age: 56 YR
• Patient Sex: Male