MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS; MULTIPLE PERIPHERAL ARTERY STENT, BARE-METAL

Device Problems Positioning Failure (1158); Difficult to Advance (2920); Premature Separation (4045)

Event Date 01/19/2021

Event Type  Injury  

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the associated study number.C1: cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.D4: device serial/lot number was requested but remains unknown.H3: code "other" was selected as the medical device remains implanted.Return not possible.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

Reportedly on (b)(6), 2021, this patient underwent an endovascular repair of a thoracoabdominal aneurysm ii which was treated with a fenestrated and branched stent graft component.During the procedure planning it was determined that the celiac trunk, superior mesenteric artery, right and left renal artery will be incorporated in the fenestrated and branched endograft.One gore® viabahn® vbx balloon expandable endoprosthesis (s/n (b)(6)) has been implanted in the superior mesenteric artery.Reportedly, the whole procedure was eventful, aortic access was successfully gained, the device was deployed as intended.The catheters were successfully removed and the patency of the device was patent at the end of the procedure.The patient received an additional antiplatelet medication during the procedure.In the same procedure two gore® viabahn® vbx balloon expandable endoprostheses were implanted successfully in the right (s/n (b)(6)) and left (s/n (b)(6)) renal artery without any complications.Reportedly one gore® viabahn® vbx balloon expandable endoprosthesis (s/n unknown) was attempted to be placed into the celiac trunk.Due to a tight stenosis the surgeon was not able to advance the vbx to the intended location.Reportedly the surgeon removed the device from the patient and took another gore® viabahn® vbx balloon expandable endoprosthesis (s/n unknown) of smaller size.Also with the second device the surgeon had difficulties to place it in the intended location in the celiac artery.At this time the surgeon noticed that the first vbx that was attempted to be placed in the celiac trunk had come off the balloon and was not removed as assumed.According to the reports the nurse did not notice on removal that the stent was no longer on the balloon.The first vbx device was noticed to be stuck in the stenosis of the celiac artery.When pushing the second vbx device in place, it also came off the balloon.Reportedly the surgeon had to snare it to retrieve it from the patient.Additionally it was reported that the vbx device stuck in the stenosis of the celiac artery contributed to a type ii endoleak that has been reported on the same day.Reportedly on (b)(6), 2021, a repeat intervention was performed due to an reported type ib endoleak on the vbx device implanted in the superior mesenteric artery (s/n (b)(6)).On (b)(6), 2021 the physician additionally indicated that a persistent type ii endoleak on the same device.The celiac trunk was retrogradely accessed and coil embolized thus treating the endoleaks in a later procedure on an unknown date.Anatomical location "other" used for "celiac trunk".

Manufacturer Narrative

Emdr section h6 codes updated to reflect results of investigation.

• Brand Name: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: MULTIPLE PERIPHERAL ARTERY STENT, BARE-METAL
• 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: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18515831
• MDR Text Key: 332874393
• Report Number: 2017233-2024-04538
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: DA
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male