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

Model Number	BXA063902A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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
On (b)(6) 2020, the patient presented with an unknown etiology in the renal artery and underwent treatment using a gore® viabahn® endoprosthesis (vsx) and three gore® viabahn® vbx balloon expandable endoprosthesis (vbx).The physician deployed the first vbx device approximately <1 cm shallow in the treatment zone.Then the physician extended the placed endoprosthesis with an additional vbx device.The physician then deployed a vsx device to line both vbx devices.While attempting to remove the rosen guidewire, the wire dislodged all of the stents and pulled the vbx & vsx devices out of the vessel.The physician was then able to snare all three devices and capture the devices for removal with a large bore sheath.A femoral cut down was then used to remove all snared devices from patient.The patient tolerated the procedure.
Additional Manufacturer Narrative
Patient information was made available and the following fields were updated: a2 - dob: (b)(6) 1937; 83 years old a3 - female h6 - investigation findings: code 213.Patient information was made available and the following field was corrected.A1 - patient identifier corrected to a.R.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10491560
• Report Number: 2017233-2020-01215
• Device Sequence Number: 3974775
• Product Code: PRL
• UDI-Device Identifier: 00733132637195
• UDI-Public: 00733132637195
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P160021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/19/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/22/2023
• Device Model Number: BXA063902A
• Device Catalogue Number: BXA063902A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 08/06/2020; 08/06/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 09/14/2021; 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 83 YR