MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS; ILIAC COVERED STENT, ARTERIAL

Catalog Number BXA097902E

Device Problems Break (1069); Difficult to Remove (1528); Failure to Advance (2524)

Patient Problem Perforation of Vessels (2135)

Event Date 01/03/2023

Event Type  Injury  

Manufacturer Narrative

Section a1: no specific patient details have been provided.Therefore the patient initials reflect the w.L.Gore reference number.H6-code b14 and c19: a review of the manufacturing records indicated the device met pre-release specifications.H6-code b13: addtional information was requested which is captured in the event description.Furthermore the vbx delivery system was requested to be returned for evaluation.Reportedly no images can be shared with gore for evaluation.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.

Event Description

It was reported to gore that on (b)(6) 2023, the patient presented with a total occlusion of the common iliac artery which was treated with a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) that was extended distally with gore® viabahn® endoprosthesis with propaten bioactive surface.Reportedly no predilatation was performed.The vbx device was advanced through an 8 fr flexor® check-flo® introducer sheath (cook medical) and deployed as intended without issues.After the device was deployed the surgeon fully deflated the vbx balloon which was confirmed by x-ray imaging, then he started to withdraw vbx delivery catheter.When entering the sheath, it became harder to move the vbx delivery catheter and then it did not move any further and reportedly could not be withdrawn.The surgeon again checked the deflation of the balloon and attempted to deflate it further.He then also tried to move the vbx delivery catheter up and down, however it would not move.The surgeon then tried to push the guidewire (amplatz super stiff 260 cm) further up through the vbx delivery catheter.Then a guidewire kink was noted requiring guidewire exchange.After guidewire exchange further attempts were made to remove the vbx delivery catheter without success.Eventually the delivery catheter hub broke off.To resolve the issue the surgeon removed introducer sheath and vbx delivery catheter as a unit from the patient.It was reported that further x-ray imaging showed blood outside the arterial walls indicating a small artery rupture occurred around the origin of the external iliac artery just below the vbx device.It could not be clarified at which step during the procedure the rupture has occurred.Reportedly, there were no patient-related conditions that contributed neither to the rupture event not to the retraction event.Reportedly no damage to the vbx device was observed, either prior to application or as a result of the difficulty encountered.To complete the planned procedure a new flexor® check-flo® introducer sheath was used to successfully delivery a new vbx device.The artery rupture was treated with the extending gore® viabahn® endoprosthesis with propaten bioactive surface.No further device was required.Reportedly the outcome was good at the end of procedure.

Manufacturer Narrative

The medical device was returned for further investigation, the device was evaluated based on the applicable procedures.A review of the manufacturing records indicated the device met pre-release specifications.Additional information was requested, the answers are captured in sections 2 and 3.Clinical images enabling direct assessment of product performance were not provided for evaluation.The risk management documents for the gore® viabahn® vbx balloon expandable endoprosthesis were reviewed.No potential new or different reasonably foreseeable risk related to the device or its use were identified based on this event.The benefit of the product has been assessed against the overall residual risk and determined that the benefit of the product outweighs the risk to the patient.Ongoing risk/benefit assessment and acceptability of residual risk serves to reaffirm risk acceptability based on current performance.No corrective measures are needed as a result of this event.Gore monitors complaints closely to ensure that risks remain within the bounds estimated in the risk management documents.Considering the event description, no further information was provided to gore, and the results of this investigation, this occurrence did not warrant remedial, corrective or preventative action in addition to no field safety action.The instructions for use (ifu) for the gore® viabahn® vbx balloon expandable endoprosthesis for the applicable region and time period was reviewed, and the following ifu statements were identified: adverse events: potential device or procedure-related adverse events adverse events which may require intervention and/or conversion to open repair include, but are not limited to: deployment failure; device failure.Based on the event description and the subsequent investigation, no further information was provided to gore, therefore we are unable to determine the cause of this incident and assign a root cause.This type of occurrence will continue to be monitored and trended for event trending analysis.Review and appropriate actions will be taken as they are deemed necessary.

• Brand Name: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: ILIAC COVERED STENT, ARTERIAL
• 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: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16264233
• MDR Text Key: 308369511
• Report Number: 2017233-2023-03665
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BXA097902E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2023
• 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
• Patient Sex: Male