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

Model Number	G35333
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Headache (1880)
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial reporter, it is alleged that [pt] received a cook zenith alpha thoracic endovascular graft proximal on (b)(6) 2018 in his mid-descending thoracic aorta.On (b)(6) 2019, [pt] presented to hospital with vomiting, diarrhea, back pain, thigh pain and headache.At that time, he was admitted.He was found to be in acute renal failure with bilateral pleural effusions.He continued to have pulmonary and renal insufficiency and was then transferred by ambulance to another hospital for a higher level of care.On (b)(6) 2019, physician performed an emergency resection and graft replacement of the descending thoracic aorta using cardio coronary bypass support and cryo-analgesia of intercostal nerves iii through vi on [pt].The preoperative and postoperative diagnosis was thrombosed descending thoracic stent graft with acute kidney failure, acute congestive heart failure, acute paraplegia from spinal ischemia and respiratory failure.

• 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: 12142725
• Report Number: 3005580113-2021-00085
• Device Sequence Number: 4170373
• Product Code: MIH
• UDI-Device Identifier: 10827002353333
• UDI-Public: (01)10827002353333(17)200411(10)E3571523
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2021
• Report Date (Section F): 07/09/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/11/2020
• Device Model Number: G35333
• Device Catalogue Number: ZTA-P-24-105-W
• Device Lot Number: E3571523
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/25/2021
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/09/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/09/2021
• 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: Required Intervention