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-42-121-W
Medical Device Problem Code	Difficult To Position (1467)
Health Effect - Clinical Codes	Death (1802); Vascular Dissection (3160)
Date of Event	10/31/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: "the zta-pt-46-42-179-w was deployed without incident over the lunderquist double curve.The second device zta-p-121-w was advanced into the primary device and it would not track, it was getting caught in the primary device.It then jumped and the nose cone of the delivery system inadvertently pushed the lunderquist wire to dissect the innominate artery." patient outcome: "[pt] is deceased.".
Additional Manufacturer Narrative
(b)(4).Summary of investigational findings: based on the imaging provided a proximal artery innominate artery dissection and possible rupture is confirmed.It cannot be confirmed if the innominate and possible ascending aortic dissection preexisted were caused by the observed tx alpha delivery system jump forwards, or occurred afterwards.The product evaluation of the returned device did not find suggesting that the device was manufactured outside of specifications.Dissection is a known complication following endovascular procedures also addressed in the instruction for use as an adverse event.Cook medical will continue to monitor for similar events.
Event or Problem Description
Description of event according to initial reporter: "the zta-pt-46-42-179-w was deployed without incident over the lunderquist double curve.The second device zta-p-121-w was advanced into the primary device and it would not track, it was getting caught in the primary device.It then jumped and the nose cone of the delivery system inadvertently pushed the lunderquist wire to dissect the innominate artery." patient outcome: "[pt] is deceased".

• 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: 6092043
• Report Number: 3002808486-2016-01366
• Device Sequence Number: 1625793
• Product Code: MIH
• UDI-Device Identifier: 10827002353654
• UDI-Public: (01)10827002353654(17)190714(10)E3472354
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P140016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2016

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: ZTA-P-42-121-W
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2016
• Supplement Report FDA Received Date: 02/21/2017
• 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: 63 YR