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

Catalog Number	ZTA-P-34-113-W
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	01/05/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).Summary of investigational findings: based on the limited amounts of information, it was not possible to confirm neither the reported event nor the root cause of the event.As per ifu aortic damage, including perforation, dissection, bleeding, rupture and death are known potential adverse effects.The work order for the complaint device appears to be complete and correct, with no evidence to suggest that the device was not manufactured according to specification.This complaint can be reopened in case further information provides support to this investigation.Cook medical will continue to monitor for similar events.
Event or Problem Description
Description of event according to complainant: the grafts were placed per ifu with ivus guidance.Post appointment ivus surveillance noted retrograde dissection into the ascending aorta.Dissection was confirmed with tee thoracic, surgery was consulted and was decided best to transfer patient to a hospital for open ascending aortic repair.Information received 09jan2017: patient follow up: patient expired post procedure in the recovery room.Patient outcome: the patient was transferred to another facility for open ascending aortic repair.Patient expired post procedure in the recovery room.

• 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; 4632 bjaeverskov; DA
• MDR Report Key: 6288750
• Report Number: 3002808486-2017-00223
• Device Sequence Number: 817376
• Product Code: MIH
• UDI-Device Identifier: 10827002353494
• UDI-Public: (01)10827002353494(17)191013(10)E3506077
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P140016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/05/2017

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: ZTA-P-34-113-W
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2017
• Initial Report FDA Received Date: 01/31/2017
• 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: Death
• Patient Age: 68 YR