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

Model Number	BXA112902A
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Aneurysm (1708); Blood Loss (2597)
Date of Event	11/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing records for the device verified the lot met all pre-release specifications.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2019 a patient was undergoing treatment of a common iliac artery stenotic lesion with gore® viabahn® vbx balloon expandable endoprostheses.There was also a distal aortic aneurysm, but it was decided this aneurysm would not be treated at this time.Following advancement of both vbx devices in kissing technique, the devices were deployed successfully.The balloons were deflated and removed.The anesthesiologist noticed a drop in the patient's blood pressure so the blood pressure cuff was checked and reapplied.However the blood pressure reading remained low.A pigtail catheter was then advanced and aortic rupture was realized.An occlusion balloon was advanced and a cook main body device was implanted.The left limb of the main body was able to be treated successfully, preserving the left iliac artery, however the right side could not be treated due to anatomical provisions so the right side was plugged with an amplatz device.For this reason, a femoral to femoral artery bypass was necessary and this was carried out by another surgeon.The patient required replacement blood products, however was stable at the end of the procedure.
Event or Problem Description
On (b)(6) 2019 a patient was undergoing treatment of a common iliac artery stenotic lesion with gore® viabahn® vbx balloon expandable endoprostheses.There was also a distal aortic aneurysm, but it was decided this aneurysm would not be treated at this time.Following advancement of both vbx devices in kissing technique, the devices were deployed with simultaneous ballooning, successfully.The balloons were deflated and removed.The anesthesiologist noticed a drop in the patient's blood pressure so the blood pressure cuff was checked and reapplied.However the blood pressure reading remained low.A pigtail catheter was then advanced and aortic rupture was realized.An occlusion balloon was advanced for hemorrhage control and a cook main body device was implanted to treat the aortic rupture.The left limb of the main body was treated successfully, preserving the left iliac artery.However, the right side could not be treated.The right side was plugged with an amplatz device.For this reason, a femoral to femoral artery bypass was necessary and this was carried out by another surgeon.The patient required replacement blood products, however was stable at the end of the procedure.
Additional Manufacturer Narrative
B.5.Updated.D.11.Additional device: bxa102902a, lot #20541811 udi: (b)(4).As it is not known which device, if either, was associated with the aortic aneurysm rupture, both were investigated.

• Brand Name: GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9405105
• Report Number: 2017233-2019-01205
• Device Sequence Number: 2230877
• Product Code: NIO
• UDI-Device Identifier: 00733132637706
• UDI-Public: 00733132637706
• Combination Product (Y/N): N
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2020

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: 06/07/2022
• Device Model Number: BXA112902A
• Device Catalogue Number: BXA112902A
• Device Lot Number: 20912735
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 02/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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: 73 YR