MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE EXCLUDERAAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	PLA260300
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	06/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The instructions for use (ifu) for the gore® excluder® aaa endoprosthesis states, adverse events that may occur and / or require intervention include but are not limited to: endoleak, occlusion of device or native vessel, rupture.
Event or Problem Description
On (b)(6) 2021, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprosthesis featuring c3® delivery system.Post deployment of the devices, imaging determined a small proximal type i endoleak.A gore® molding & occlusion balloon (mob) was used to perform additional angioplasty of the proximal trunk.During angioplasty it was reported that the mob was placed with a small portion of the balloon outside the proximal trunk and within the aorta, causing a rupture of the aorta at the level of the renal arteries due to overinflation of the mob.The patient underwent multiple transfusions while receiving treatment of the rupture.Four gore® aortic extenders components and two palmz 40x10 stents were implanted to treat the rupture.The renal arteries were intentionally covered and the aorta was grafted up to the level of the superior mesenteric artery (sma).The patient tolerated the procedure and was transferred to the intensive care unit in critical condition.The patient expired due to cardiac failure at 11:00pm this same day.

• Brand Name: GORE EXCLUDERAAA ENDOPROSTHESIS
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 12185980
• Report Number: 3013164176-2021-01214
• Device Sequence Number: 1622164
• Product Code: MIH
• UDI-Device Identifier: 00733132618774
• UDI-Public: 00733132618774
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/16/2021

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: 05/30/2022
• Device Model Number: PLA260300
• Device Catalogue Number: PLA260300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 07/16/2021
• 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; Other
• Patient Weight: 68