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

Model Number	BXA087902A
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device information: bxa087902a serial number: (b)(4) udi: (b)(4) as it is not known which device became separated from the other, both devices are being investigated.
Event or Problem Description
On (b)(6) 2020 a patient underwent an endovascular procedure in the (b)(6) study.Gore® viabahn® vbx balloon expandable endoprostheses were utilized in the branch vessels.On (b)(6) 2020 imaging revealed that the two vbx devices which were deployed in the superior mesenteric artery had become separated.On (b)(6) 2020 a reintervention to treat the type iii endoleak was performed.An additional vbx was deployed to bridge the separation and the endoleak was considered resolved.The patient tolerated the procedure.On (b)(6) 2020 the patient was discharged.
Additional Manufacturer Narrative
Additional manufacturer narrative: cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.H.6.Results code 1: 213: a review of the manufacturing records for the device verified the lot met pre-release specifications.
Additional Manufacturer Narrative
H.6.Results code 1: 213 a review of the manufacturing records for both devices verified the lots met all pre-release specifications.

• 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: 10813680
• Report Number: 2017233-2020-01433
• Device Sequence Number: 3798809
• Product Code: PRL
• UDI-Device Identifier: 00733132637799
• UDI-Public: 00733132637799
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/21/2021

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: 03/30/2023
• Device Model Number: BXA087902A
• Device Catalogue Number: BXA087902A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 12/28/2020; 01/13/2021
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 01/12/2021; 01/21/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H.10./11.
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 62