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

Catalog Number	ZTA-PT-44-40-179-W
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Summary of investigational findings: by the provided information and investigation of the returned product it was possible to confirm that the tip of the flexor® introducer sheath is a bit stretched.It was not possible to determine the exact root cause of the event.However, it is likely to be caused by patient anatomy, as it was stated to be tortuous.As per the ifu the zenith alpha thoracic endovascular graft is indicated for the endovascular treatment of patients having vascular anatomy suitable for endovascular repair.Careful evaluation of vessel size and anatomy is required to ensure successful sheath introduction and subsequent withdrawal, as vessels that are significantly calcified, occlusive, tortuous, or thrombus lined may preclude introduction of the endovascular graft.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.Cook medical will continue to monitor for similar events.
Event or Problem Description
Description of event according to initial reporter: "there was difficulty tracking the device due to tortuosity.Because of the tortuosity, it appears the dilator stretched the tip of the sheath.We took the device out to switch out for a double curved lunderquist.When trying to re-advance the device, we noticed that the tip of the sheath was stretched out preventing us to continue to advance through the iliac system.We removed the device and put in a 24fr.Chek-flo sheath into the distal abdominal aorta.The alpha device/sheath was advanced over the wire, through the 24fr sheath into proper position.It was deployed without any difficulty." 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.

• Brand Name: ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; 4632 bjaeverskov; DA
• MDR Report Key: 6188346
• Report Number: 3002808486-2016-01496
• Device Sequence Number: 955924
• Product Code: MIH
• UDI-Device Identifier: 10827002382081
• UDI-Public: (01)10827002382081(17)190310(10)E3425535
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/14/2016

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-PT-44-40-179-W
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2016
• Initial Report FDA Received Date: 12/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR