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	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Description of event according to initial reporter: there appears to be a type 1a endoleak at the proximal end of the alpha thoracic graft, just distal to the l.Subclavian artery (lsa).The final set of images we have are from (b)(6) 2019, and these show that the proximal type 1a endoleak has been fixed by extending the alpha graft proximally to cover the lsa, the lsa itself has been coil embolized to prevent backflow, and the extension of the graft back into the arch has been fixed using aptus screws into the aortic wall.(b)(6) 2019: proximal extension of thoracic endograft with a cook zta-pt 42 x 38 covering the left subclavian artery, placement of thoracic endograft cook zta-p 38 x 167 between the connection of the previous tevar and branch graft.Placement of 3 aptus screws in the proximal thoracic stent graft.Coil embolization of left subclavian artery.Per (b)(6) (manufacturer report # 3002808486-2021-01881): on (b)(6) 2019: proximal extension of thoracic endograft with a cook zta-pt 42 x 38 covering the left subclavian artery, placement of thoracic endograft cook zta-p 38 x 167 between the connection of the previous tevar and branch graft.Placement of 3 aptus screws in the proximal thoracic stent graft.Coil embolization of left subclavian artery.Balloon angioplasty of superior mesenteric artery stent and left renal artery stent with a 10 x 2 balloon.

• 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: 13260598
• Report Number: 3005580113-2022-00015
• Device Sequence Number: 19999479
• Product Code: MIH
• UDI-Device Identifier: 10827002353593
• UDI-Public: (01)10827002353593(17)191025(10)E3510679
• 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): 01/14/2022
• Report Date (Section F): 01/12/2022

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: 10/25/2019
• Device Model Number: G35359
• Device Catalogue Number: ZTA-P-38-167-W
• Device Lot Number: E3510679
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/22/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/12/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/14/2022
• Date Device Manufactured: 10/25/2016
• 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: Required Intervention
• Patient Sex: Unknown