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

Device Problem Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2024

Event Type  Injury  

Event 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
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 18630473
• MDR Text Key: 334428915
• Report Number: 3005580113-2024-00011
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002381800
• UDI-Public: (01)10827002381800(17)261012(10)E4460006
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Date Report Sent to FDA: 02/02/2024
• Distributor Facility Aware Date: 01/12/2024
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/15/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/02/2024
• Date Device Manufactured: 10/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention