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

Catalog Number	ZTA-PT-38-34-167-W
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Description of event according to initial reporter.A patient of undisclosed gender and age underwent a tevar (thoracic endovascular aortic repair) procedure in which the zenith alpha thoracic endovascular graft proximal tapered components, was used.When the graft was unsheathed in the patient the third stent from the top would not open fully.It was constrained about fifty percent.The surgeon used a coda balloon to open the stent successfully.It was a dissection, patient had some tears in their aorta patient outcome: district manager contacted the surgeon one day post-op and surgeon confirmed the patient was doing well.

• Brand Name: ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED 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: 18630473
• Report Number: 3005580113-2024-00011
• Device Sequence Number: 15386365
• Product Code: MIH
• UDI-Device Identifier: 10827002381800
• UDI-Public: (01)10827002381800(17)261012(10)E4460006
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/02/2024
• Report Date (Section F): 02/02/2024

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 Catalogue Number: ZTA-PT-38-34-167-W
• Device Lot Number: E4460006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/12/2024
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/15/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2024
• Date Device Manufactured: 10/12/2023
• 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
• Date Report Sent to FDA: 02/02/2024