MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	ZTEG-2PT-40-158-PF-US
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	01/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Summary of investigational findings: based on the limited amounts of information available, it was not possible to determine 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 zenith tx2 taa endovascular graft was placed per ifu with great outcome resolving the patient¿s pain.About 30 hours post op the patient had dissected retrograde into the ascending aorta.The patient was transferred to another facility for open aortic repair.Patient outcome.The patient was transferred to another facility for open aortic repair.It is unknown at this time the patients condition.

• Brand Name: ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; 4632 bjaeverskov; DA
• MDR Report Key: 6288748
• Report Number: 3002808486-2017-00222
• Device Sequence Number: 810598
• Product Code: MIH
• UDI-Device Identifier: 10827002534503
• UDI-Public: (01)10827002534503(17)170828(10)E3249618
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P070016
• 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: ZTEG-2PT-40-158-PF-US
• 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: Life Threatening