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

Model Number	G35335
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
Description of event according to tweet: tweet: have you ever seen a new dissection flap inside a stendt graft? tweet: i have @washuvascular.26 mm @cookvascular alpha placed for aberrant l sca (left subclavian artery) in a right sided arch.Presented with htn (hypertension) and aki (acute kidney injury) to clinic.50 mmhg pressure differential, looked like delaminated thrombus on #ivus (intravascular ultrasound).Patient outcome: unknown.

• 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: 14461609
• Report Number: 3005580113-2022-00060
• Device Sequence Number: 4482677
• Product Code: MIH
• UDI-Device Identifier: 10827002353357
• UDI-Public: (01)10827002353357(17)190321(10)E3430020
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/20/2022
• Report Date (Section F): 05/19/2022

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: 03/21/2019
• Device Model Number: G35335
• Device Catalogue Number: ZTA-P-26-105-W
• Device Lot Number: E3430020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/20/2022
• Date Device Manufactured: 03/21/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown