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

Model Number BXA082901A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/17/2021

Event Type  Injury  

Manufacturer Narrative

Review of device manufacturing record history confirmed device met pre-release specifications.The stent remains implanted.The balloon was not removed from patient.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

The following was reported to gore: on (b)(6) 2021, patient presented for treatment of occlusive common iliac arteries.Access was bilateral femoral arteries and a kissing stent technique was used at the bifurcation.Both of the gore® viabahn® vbx balloon expandable endoprostheses (vbx device) reached the target treatment area and deployed with no issues.However, after device expansion one balloon could not be deflated.The physician attempted to deflate the balloon by over-inflation in order to burst the balloon, and also using a tips/septal needle to puncture the balloon.During use of needle, an artery was punctured, creating a perforation.A gore® viabahn® endoprosthesis was used to cover the perforation.As balloon remained inflated, a retroperitoneal exposure of the iliac artery was necessary to deflate the balloon.The deflated balloon was then covered with a stent.The balloon remained in the patient due to hemodynamic instability.The broken catheter was removed from the patient.As reported, the balloon remained attached to catheter during attempts to deflate, there were no pre-existing stents, and a hybrid approach was used.It was also reported the patient coded two times during the procedure.The patient was transferred to icu for observation.On (b)(6) 2021, the patient had a cardiac arrest and expired.

Event Description

A copy of user facility medwatch report was received by email (see attachment).Event description states: during a bilateral common iliac artery stenting procedure, surgeon used balloon expandable stents.Both stents were advanced to the area of deployment under direct fluoroscopy and deployed.Upon deployment of the stents, the balloon within the right common iliac artery stent would not deflate, resulting in extravasation, which led to patient coding during the procedure from hemorrhagic shock.Source of bleeding found and controlled, blood products administered, and patient stabilized on pressors.Patch angioplasty performed, skin suture and patient transferred to icu where he later expired.

Manufacturer Narrative

The specific cause of the inability to deflate the device could not be confirmed.Gore did not receive the device for evaluation.Specific information regarding the deflation technique was not provided.There is uncertainty in assessment of specific factors affecting deflation: the actual deflation rate and the concentration of contrast used.The ifu provides instruction related to balloon deflation.The investigation confirms the complaint of difficult/inability to deflate the balloon but is unable to assign cause.No information was provided related to the reported catheter break and it is assumed it was related to events subsequent to the inability to deflate the device.A product history review was conducted for the vbx device, and the review of the manufacturing records indicated the lot met pre-release manufacturing specifications.H1 - correction (to serious injury).

• 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
• MDR Report Key: 11467570
• MDR Text Key: 239348795
• Report Number: 2017233-2021-01757
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 00733132637546
• UDI-Public: 00733132637546
• Combination Product (y/n): Y
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/21/2022
• Device Model Number: BXA082901A
• Device Catalogue Number: BXA082901A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 77 YR