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

Catalog Number	ZTA-D-40-197-W
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/04/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Patient identifier: unknown as information was not provided.Age at time of event, date of birth: unknown as information was not provided.Weight: unknown as information was not provided.Investigation is still in progress.
Event or Problem Description
Description of event according to complainant: device was being deployed and the final rotation of the handle was performed, but the top stent was not released.We then had to use the fail-safe mechanism in order to fully deploy the top.Patient outcome: the patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Summary of investigational findings: based on the provided information it was not possible to determine the root cause of this event.The device was not returned to support the investigation; however, the reported difficulty was solved by following the instruction for use.No evidence to suggest that the device was not manufactured according to specification.Cook medical will continue to monitor for similar events.
Event or Problem Description
Description of event according to initial reporter: device was being deployed and the final rotation of the handle was performed, but the top stent was not released.We then had to use the fail-safe mechanism in order to fully deploy the top.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT DISTAL COMPONENTS
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; 4632 bjaeverskov; DA
• MDR Report Key: 5590218
• Report Number: 3002808486-2016-00234
• Device Sequence Number: 348774
• Product Code: MIH
• UDI-Device Identifier: 10827002353982
• UDI-Public: (01)10827002353982(17)181023(10)E3378917
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P140016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ZTA-D-40-197-W
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/20/2016
• Supplement Report FDA Received Date: 12/02/2016
• 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: Other