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

Catalog Number BXA077902E

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

Patient Problem Aneurysm (1708)

Event Date 06/21/2021

Event Type  malfunction  

Manufacturer Narrative

Phr-review: a review of the manufacturing records indicated the lot met pre-release manufacturing specifications.Cbas¿ heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

It was reported to gore that patient underwent endovascular treatment for an aneurysm in the internal iliac artery with a gore¿ viabahn¿ vbx balloon expandable endoprosthesis (vbx-device).It was stated that a first viabahn-device was implanted without any problems.Then a second prosthesis was advanced to the lesion and when dilating the balloon with about 4 atm the balloon burst.It was tried to remove the balloon, but this was not possible, as it got stuck in the vbx-device.With a second balloon the vbx-device was deployed with nominal pressure, but not at the intended position.Then the balloon could be removed.Reportedly 2 additional vbx-devices had to be implanted to exclude the aneurysm.The patient tolerated the procedure and is being fine.

Manufacturer Narrative

Engineering evaluation it was reported to gore that patient underwent endovascular treatment for an aneurysm using a vbx device.When dilating the balloon, the balloon reportedly burst leaving the endoprosthesis partially expanded.The balloon was reportedly stuck on the partially expanded endoprosthesis initially during removal, and this is consistent with the observed distal bunching of the balloon shown in.Eventually, the endoprosthesis separated from the balloon during withdrawal.The returned device was confirmed as a gore® viabahn® vbx balloon expandable endoprosthesis device (7 x 79 mm, with 135 cm delivery system).Returned product had no endoprosthesis present but it is unclear from the event description how the crimped endoprosthesis came off (i.E.Dislodgement or partial inflation) balloon: witness marks are present on the balloon cover potentially indicating it was not inflated.Distal balloon cover material is folded/bunched distally indicating a possible dislodgement force.Using an inflation device with 12 ml of water, inflation was attempted.After only a few turns of the inflation device the pressure gauge read 12 atm while no inflation had begun.Vacuum was pulled and inflation was attempted a second time, but the balloon still did not inflate.Catheter: minor knicks/scratches observed as catheter damage at 13, 64.5, 74, and 99 cm from shrink sleeve tubing.Vacuum was pulled and maintained on inflation port using a 12 ml syringe and 4 ml of water indicating no leakage bubbles observed in the hub indicate a pathway, or no blockage, is present within the hub component.No leakage was observed initially; however, inflation would also not occur.Balloon inflation fluid did not initially travel the full length of the catheter.The cause of the primary reported issue, that there was a balloon rupture during inflation, could not be determined, because engineering evaluation did not find a ruptured or burst balloon.Evaluation of the returned device finds a damaged dual lumen.Initially, attempts to inflate the balloon were unsuccessful.A blockage was observed 44 cm from the shrink sleeve tubing when a 0.014"abbott hi-torque spartacore 14 guide wire was attempted to be passed through the inflation lumen.Complete resistance was felt at the 44 cm location, and the inflation lumen blockage appears to be blood.A subsequent attempt to inflate the balloon with water resulted in audible confirmation of fluid reaching the balloon and visual observation of fluid passing the inflation lumen blockage.Once fluid surpassed the inflation lumen blockage fluid began leaking radially outward from the dual lumen, and the balloon would still not inflate.The cause for neither the leak nor the blockage could be confirmed because it is unknown whether the leak existed prior to the procedure or occurred as a resulted of procedural manipulation.Returned product evaluation confirms the failure mode for ¿lumen damaged, catheter will partially inflate, but not hold pressure¿, but the cause of the device failure mode cannot be confirmed.

• 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: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12196682
• MDR Text Key: 262505448
• Report Number: 2017233-2021-02185
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2023
• Device Catalogue Number: BXA077902E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2020
• 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 Age: 74 YR
• Patient Sex: Male
• Patient Weight: 90 KG