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-46-125-W
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: "during a taa procedure the physician had difficulty initiating the unsheathing of the device.At this point the physician did not feel comfortable proceeding with the device and it was removed.The procedure was finished with another of the same device".Patient outcome: the patient didn't have any adverse effects due to this occurence.
Additional Manufacturer Narrative
(b)(4).Summary of investigational findings: the deployment force of this device was measured, showing 46.7 n, which is acceptable.No visual irregularities of the device were observed.Based on the available information it was not possible to determine the exact root cause of the event.A likely root cause is tortuous patient anatomy.Imaging of patient anatomy was requested, but not provided.Without imaging, no conclusions can be drawn.If additional information is received, the complaint file can be reopened and investigated again.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: "during a taa procedure the physician had difficulty initiating the unsheathing of the device.At this point the physician did not feel comfortable proceeding with the device and it was removed.The procedure was finished with another of the same device".Patient outcome: the patient didn't have any adverse effects due to this occurence.

• 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: 6217605
• Report Number: 3002808486-2016-01610
• Device Sequence Number: 415408
• Product Code: MIH
• UDI-Device Identifier: 10827002353739
• UDI-Public: (01)10827002353739(17)190622(10)E3462743
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P140016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2017

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-P-46-125-W
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/03/2017
• Supplement Report FDA Received Date: 03/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1