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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/02/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Description of event according to initial reporter: "component separation.Secondary procedure done.(separation between alpha 38 and main body).On (b)(6) 2017:thoracic endograft (alpha 38x167).Right groin cutdown.Ultrasound-guided access of left common femoral artery.(b)(4).On (b)(6) 2018: component separation seen on x-ray.On (b)(6) 2018: tevar re-lining distal dta between previous tevar and fenestrated endografts with 40x150mm gore ctag.((b)(4)).Patient outcome: patient tolerated the procedures.

• 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: 12713206
• Report Number: 3005580113-2021-00132
• Device Sequence Number: 20027315
• Product Code: MIH
• UDI-Device Identifier: 10827002353593
• UDI-Public: (01)10827002353593(17)200720(10)E3609984
• 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: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/28/2021
• Report Date (Section F): 10/28/2021

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: 07/20/2020
• Device Model Number: G35359
• Device Catalogue Number: ZTA-P-38-167-W
• Device Lot Number: E3609984
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/01/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/27/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2021
• 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: 10/28/2021