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

Model Number G38075

Device Problems Off-Label Use (1494); Difficult to Remove (1528); Device Damaged Prior to Use (2284); Migration (4003)

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

Event Date 10/20/2021

Event Type  Injury  

Event Description

Description of event according to initial reporter: upon deployment of the modified graft, the delivery system was in the process of being removed when it seemed to get caught up on the graft as it was being removed.It was then noticed that the graft seemed to have moved distal to where it was released causing a shift from where it was originally at.The celiac artery was then unable to be cannulated.It was noted after finally removing the delivery system that one of the trigger wires was still able to be seen on the system where it should have been rotated into the handle.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The patient did not require any additional procedures due to this occurrence.

• 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: 12804386
• MDR Text Key: 280768764
• Report Number: 3005580113-2021-00137
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002380759
• UDI-Public: (01)10827002380759(17)240413(10)E4096081
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/11/2021,11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G38075
• Device Catalogue Number: ZTA-PT-32-28-178-W
• Device Lot Number: E4096081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2021
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/20/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/11/2021
• Date Device Manufactured: 04/13/2021
• 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
• Patient Age: 73 YR
• Patient Sex: Male