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-46-233-W
Medical Device Problem Codes	Leak/Splash (1354); Difficult To Position (1467)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: "the zenith alpha¿ thoracic endovascular graft was implanted on (b)(6) 2017.The district manager noted that the bottom edge of the stent caught on the delivery system¿s preform causing the bottom edge of the stent to move back approximately 1cm from the landing zone.No endoleak was noted at that time and the dr.Indicated there was no failure with the procedure.Now a type 1a endoleak has been noted." patient outcome: no patient information available, future procedures are pending.
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).A1) unknown as information was not provided.A2) unknown as information was not provided.A3) unknown as information was not provided.A4) unknown as information was not provided.B3) unknown as information was not provided.F9) unknown as date of event is unknown.G1) name and address for importer site: cook medical incorporated (cmi) 400 daniels way bloomington, in 47404 registration no.: 3005580113.(b)(4).Summary of investigational findings: based on the limited information provided it was not possible to determine the root cause of the reported event.As per ifu the sheath should be withdrawn until the graft is fully expanded and the valve assembly with the captor sleeve docks with the black gripper.If the sheath is not fully withdrawn the bottom edge of the graft might get caught in the delivery system.The reported type 1a endoleak is a possible result of the reported 1 cm antegrade movement of the graft.Depending on planned sealing zone the movement might result in a sealing zone less than 20 mm, increasing risk of endoleak.The endoleak might be resolved by placement of additional endovascular grafts and extensions.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.
Event or Problem Description
Description of event according to initial reporter: "the zenith alpha¿ thoracic endovascular graft was implanted on (b)(6) 2017.The district manager noted that the bottom edge of the stent caught on the delivery system¿s preform causing the bottom edge of the stent to move back approximately 1cm from the landing zone.No endoleak was noted at that time and the dr.Indicated there was no failure with the procedure.Now a type 1a endoleak has been noted." patient outcome: no patient information available, future procedures are pending.

• 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: 6405310
• Report Number: 3002808486-2017-00830
• Device Sequence Number: 18974005
• Product Code: MIH
• UDI-Device Identifier: 10827002353760
• UDI-Public: (01)10827002353760(17)190711(10)E3470277
• 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
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2017

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: ZTA-P-46-233-W
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/06/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/15/2017
• Supplement Report FDA Received Date: 05/04/2017
• 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