MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G53450
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	11/12/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Description of event according to the initial reporter: component separation.On (b)(6) 2016: index procedure: cook 4-vessel custom branched endograft with taa proximal extension (zteg, esbe and tbe) on (b)(6) 2020: component separation between the custom endograft and taa extension -> repaired with alpha ((b)(4)) on (b)(6) 2021: patient was transferred from an outside hospital with symptomatic taaa/separation of alpha graft from custom endograft -> due to other comorbidities, no intervention was performed ((b)(4)).

• Brand Name: ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT
• 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: 12680727
• Report Number: 3005580113-2021-00125
• Device Sequence Number: 19840561
• Product Code: MIH
• UDI-Device Identifier: 10827002534503
• UDI-Public: (01)10827002534503(17)170826(10)E3248656
• 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): 10/22/2021
• Report Date (Section F): 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/26/2017
• Device Model Number: G53450
• Device Catalogue Number: ZTEG-2PT-40-158-PF-US
• Device Lot Number: E3248656
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/27/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/21/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2021
• 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: 10/22/2021