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

Model Number	G35523
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/09/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Description of event according to the initial reporter: component separation.On (b)(6) 2020: endovascular repair of ruptured aaa with endovascular grafts; (b)(6) 2020: type iii endoleak repair of 2 aortic cuffs.No detailed information is available as these procedures were performed at outside facility.Patient outcome: no information regarding the patient has been received.

• Brand Name: ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT DISTAL EXTENSIONS
• 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: 12697978
• Report Number: 3005580113-2021-00127
• Device Sequence Number: 3855258
• Product Code: MIH
• UDI-Device Identifier: 10827002355238
• UDI-Public: (01)10827002355238(17)190329(10)E3431552
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 10/26/2021
• Report Date (Section F): 10/26/2021

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: 03/29/2019
• Device Model Number: G35523
• Device Catalogue Number: ZTA-DE-38-91-W
• Device Lot Number: E3431552
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/26/2021
• 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
• Date Report Sent to FDA: 10/26/2021