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

Model Number	BXA061902A
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
H6.Codes updated to reflect completed investigation: investigation findings: code 213.Investigation conclusions: code 4315.Patient information was made available and the following fields were updated: a2.Dob: (b)(6) 1937; 83 years old.A3.Female 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: 10491595
• Report Number: 2017233-2020-01216
• Device Sequence Number: 17137443
• Product Code: PRL
• UDI-Device Identifier: 00733132637171
• UDI-Public: 00733132637171
• 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
• 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: 09/10/2022
• Device Model Number: BXA061902A
• Device Catalogue Number: BXA061902A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 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