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

Model Number	BXA082901A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/17/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 11467570
• Report Number: 2017233-2021-01757
• Device Sequence Number: 4041655
• Product Code: PRL
• UDI-Device Identifier: 00733132637546
• UDI-Public: 00733132637546
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/21/2022
• Device Model Number: BXA082901A
• Device Catalogue Number: BXA082901A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 06/01/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 77 YR