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

Catalog Number BXA051902E

Device Problems Break (1069); Fluid/Blood Leak (1250)

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

Event Date 09/27/2022

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: patient information has been requested from the physician.The answer is pending.The gore case reference number was used as the patient identifier instead.Device evaluated by mfr: the device was requested for evaluation.The return is pending.Request were emailed to the physician to further clarify the incident.The provided information is captured in the description.A review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.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

The patient underwent an endovascular procedure for an abdominal aneurysm that was treated with a fenestrated non-gore endograft.A gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) was used as a bridging device to a renal artery.The device was advanced to the intended location and the balloon was inflated to only 8 atm to deliver the vbx endoprosthesis and to prevent from distal dissection of the renal artery.Then the balloon was fully deflated and retracted by 1cm, so the proximal end of the balloon was inside the aorta proximal to the fenestration.Then they started to reinflate the balloon to nominal pressure.During reinflation the balloon has burst.They presume that it burst at 8 atm.The physician has no suspects as to why the balloon has burst.Reportedly there were no issues with advancement of the device to the target location, there were no sharp subjects at the location of the 2nd inflation, like anchors of the aortic mainbody, or calcification, there were no general issues with inflation or deflation of the balloon, there were no special issues with the balloon i.E.Non-uniform balloon expansion, there were no difficulty / snagging experienced during the 1 cm retraction, and the balloon did not interact with the fenestrated graft during the subsequent inflation.It was also reported that they did not pre-dilatate the balloon during preparation.They stated that this is not common practice with aortic procedures where a vbx device is used as a branch device to the renal artery.It was reported that the defective balloon delivery catheter was withdrawn from the patient, and a percutaneous transluminal angioplasty (pta) balloon dilatation catheter was used to perform the second ballooning.Reportedly there was no harm to the patient and the patient is doing well.

Manufacturer Narrative

Cause investigation and conclusion: a review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.The balloon delivery catheter of the device was returned for evaluation.The evaluation summary states the following: the reported balloon rupture, was not confirmed during the evaluation as it was determined that the balloon was leaking intermittently through the stem tubing, between the marker bands.The device was imaged using ct, with inconclusive results, prompting a dissection of the device.Upon dissecting the device and pressurizing the guidewire lumen while submerging (the stem tubing) in water, bubbles were identified as coming from the middle of the stem tubing indicating a leakage pathway.Based on supplier controls, in-process inspections, and the available complaint information, a root cause cannot be established.Based on this evaluation finding the incident no longer meet the criteria of a reportable event of a balloon rupture inside the patient.Therefore, this incident is reported as a non-reportable incident.

Event Description

The patient underwent an endovascular procedure for an abdominal aneurysm that was treated with a fenestrated non-gore endograft.A gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) was used as a bridging device to a renal artery.The device was advanced to the intended location and the balloon was inflated to only 8 atm to deliver the vbx endoprosthesis and to prevent from distal dissection of the renal artery.Then the balloon was fully deflated and retracted by 1cm, so the proximal end of the balloon was inside the aorta proximal to the fenestration.Then they started to reinflate the balloon to nominal pressure.During reinflation the balloon has burst.They presume that it burst at 8 atm.The physician has no suspects as to why the balloon has burst.Reportedly there were no issues with advancement of the device to the target location, there were no sharp subjects at the location of the 2nd inflation, like anchors of the aortic mainbody, or calcification, there were no general issues with inflation or deflation of the balloon, there were no special issues with the balloon i.E.Non-uniform balloon expansion, there were no difficulty / snagging experienced during the 1 cm retraction, and the balloon did not interact with the fenestrated graft during the subsequent inflation.It was also reported that they did not pre-dilatate the balloon during preparation.They stated that this is not common practice with aortic procedures where a vbx device is used as a branch device to the renal artery.It was reported that the defective balloon delivery catheter was withdrawn from the patient, and a percutaneous transluminal angioplasty (pta) balloon dilatation catheter was used to perform the second ballooning.Reportedly there was no harm to the patient and the patient is doing well.

• 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: 15638383
• MDR Text Key: 302327612
• Report Number: 2017233-2022-03417
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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: 12/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: BXA051902E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2022
• 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