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

Catalog Number BXA075902E

Device Problems Difficult to Insert (1316); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2022

Event Type  Injury  

Manufacturer Narrative

No patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.The device is in transit to gore manufacturing site and evaluation will be commenced once its received.(b)(4).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

Reportedly, the catheter delivery system was compromised with what looked like a kink or a crimp.This was noticed when the physician tried to feed it onto the wire.It was reported that the device was never actually implanted in the patient.It has been kept in order and can be returned for further investigation.Furthermore, according to the physician's assessment, it was believed that the event is not a gore® viabahn® vbx balloon expandable endoprosthesis product issue.The physician believed that the catheter feed was being compromised by another product in situ.The following are the physician's words, they update and replace the initial information provided by the associate on (b)(6) 2022, the patient underwent a branched endovascular aneurysm repair procedure where a 12 fr 45 cm cook ansel modification sheath was introduced from right axillary artery into descending aorta through a 8.5 fr (inner diameter) 90 cm (working length) medtronic tourguide sheath.One of the renal arteries was cannulated and stented with a gore® viabahn® vbx balloon expandable endoprosthesis through these two sheaths (either rosen or amplatz wire was used) while the second renal artery wasn't cannulated.Furthermore, the superior mesenteric artery was cannulated.Reportedly, while advancing the vbx, the physician indicated that he experienced a resistance/catch half-way through the tourguide sheath.The physician mentioned that with a non-excessive force, the vbx was advanced and successfully deployed in the superior mesenteric artery.The physician is of the opinion that the issue was somehow with the tourguide sheath, rather than the vbx stent-graft or catheter.Reportedly, the coeliac axis was equally cannulated.While advancing the vbx, a similar resistance was experienced once again, when extra force was applied the vbx catheter concertinaed externally.The physician considered it unsafe to try to push it any further, therefore the vbx was removed and retained.The tourguide sheath was removed and the coeliac axis was stented with an atrium advanta ( according to the phyisician, the choice to use atrium advanta was purely because we had no more of the specific size of vbx left) through the ansel sheath alone it was reported that the left renal artery was cannulated and the vbx was successfully deployed.The tourguide sheath was not reused.External assessment of the tourguide sheath revealed no kink or defect.The physician wondered if the 'resistance' was at the aortic arch, which was reasonably steep.No prior screening was performed to discover where the vbx got caught because the first vbx only got caught transiently and the second vbx was removed as soon as the catheter became damaged.

Manufacturer Narrative

Further review of the complaint determined the device did not cause or contribute to a serious injury nor did it malfunction in a manner that could lead to a serious injury.Therefore, this report is non-reportable and is being retracted.

• 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: wilson okeke ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15500504
• MDR Text Key: 300763299
• Report Number: 2017233-2022-03362
• 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: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: BXA075902E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male