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

Model Number	G38190
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/23/2017
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: the device would not deploy and the sheath elongated and stretched.The physician aborted utilizing the device and used a competitors to complete the procedure.Patient outcome: the patient did not require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer ref# (b)(4).G1) name and address for importer site: cook medical incorporated (cmi) 400 daniels way bloomington, in 47404 registration no.: 3005580113.Summary of investigational findings: examination of the device was not possible as the product was not returned.Images show a severely tortuous descending thoracic aorta with three different 90-degree angles.Though the delivery device appears to conform to the tortuous anatomy as it is advanced to the aortic arch, the severe degree of angulation is outside the ifu for repair using this device.The ifu states that anatomic elements that may affect successful exclusion of the thoracic lesion include severe angulation, including localized angulation > 45 degrees.The most likely root cause of the reported event is the servere degree of angulation of descending thoracic aorta outside of ifu.No evidence to suggest that the device was not manufactured according to specification.Cook medical will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 6386531
• Report Number: 3002808486-2017-00718
• Device Sequence Number: 16277828
• Product Code: MIH
• UDI-Device Identifier: 10827002381909
• UDI-Public: (01)10827002381909(17)190429(10)E3443940
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P070016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2017

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 Model Number: G38190
• Device Catalogue Number: ZTA-PT-38-34-217-W
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/23/2017
• Device Age: 10 MO
• Initial Date Received by Manufacturer: 02/24/2017
• Supplement Date Received by Manufacturer: 02/24/2017
• Initial Report FDA Received Date: 03/08/2017
• Supplement Report FDA Received Date: 07/06/2017
• 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: Other