MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G35359
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	10/07/2021
Type of Reportable Event	Death
Event or Problem Description
Description of event according to initial reporter: complete debranching of the aortic arch all vessels re-located to the ascending aorta via open repair landing the alpha thoracic graft in the ascending aorta at the anastomosis of arch branch vessels.Physician pulled the device sheath and patient became hypotensive, physician inserted a 20fr sheath and patient became so sick that they needed to go on cardio pulmonary bypass then cpr needed to be performed and patient put on circulatory arrest.Because of cpr the sutures of the anastomosis in the arch broke requiring the anastomosis to be redone.The 20fr sheath was replaced with a 21fr cannula used for the bypass machine.Surgeon had to open abdomen because patient had developed intrabdominal compartment syndrome due to all the fluids he received through out case.When they pulled the sheath the final time his pressures plummeted again and it became clear he had a significant retroperitoneal bleed.Injury to external iliac artery believed to be caused by the delivery system even though delivered over a lunderquist wire.Additional information received 18-oct-2021: we had a thoracic endograft going up with fixed images after our initial angiogram.It was only suspect after the device was removed (likely tamponode) until after we removed and pressure fell.Temporized with 20 fr sheath that went back up.Further diagnosis complicated by 21 fr cardiac cannula that went up to put patient on cardiopulmonary bypass.After that sheath was removed patient had a major retroperitoneal bleed that led to the final diagnosis that was otherwise difficult to achieve (full aorto/ iliac angiogram was earlier done, by cpb cannula was likely tamponoding the eia).'" patient outcome: the precurved cannula of the alpha graft dragged across the iliac causing an iliac rupture causing death of the patient.Patient passed away before getting off the or table.

• Brand Name: ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 12743746
• Report Number: 3005580113-2021-00135
• Device Sequence Number: 17146900
• Product Code: MIH
• UDI-Device Identifier: 10827002353593
• UDI-Public: (01)10827002353593(17)240510(10)E4106914
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/03/2021
• Report Date (Section F): 11/03/2021

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: 05/10/2024
• Device Model Number: G35359
• Device Catalogue Number: ZTA-P-38-167-W
• Device Lot Number: E4106914
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/08/2021
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/02/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/03/2021
• 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: Death
• Patient Age: 72 YR
• Date Report Sent to FDA: 11/03/2021