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

Model Number	G35333
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	Paraplegia (2448)
Date of Event	02/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturers ref# (b)(4).G1) name and address for importer site: cook medical incorporated (cmi) 400 daniels way bloomington, in 47404 registration no.: 3005580113.(b)(4).Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: patient formed distal thrombus and the stent became inclusive causing paralysis of the legs.This required a re-intervention with a gore endograft which seems to have opened the lumen but the patient seems to still have some paralysis.Patient outcome: the patient required additional procedures due to this occurrence, re-intervention with endograft.Paralysis of the legs.
Additional Manufacturer Narrative
Exemption number e2016032.(b)(4).Manufacturers ref# (b)(4).(b)(4).Summary of investigational findings: the complaint states that a patient received a zta-p-24-105-w device on (b)(6) 2017 to repair a traumatic injury.The patient underwent a secondary procedure with another device to open the lumen of the stent graft.No images were provided.Based on the information provided, it was not possible to determine the root cause of the reported event.Cook will reopen its investigation if further information is received.There is no evidence to suggest that the device was not manufactured according to specification.Cook medical will continue to monitor for similar events.

• 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; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 7315684
• Report Number: 3002808486-2018-00304
• Device Sequence Number: 16169090
• Product Code: MIH
• UDI-Device Identifier: 10827002353333
• UDI-Public: (01)10827002353333(17)191221(10)E3533574
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2018

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 Model Number: G35333
• Device Catalogue Number: ZTA-P-24-105-W
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/20/2018
• Device Age: 14 MO
• Initial Date Received by Manufacturer: 02/19/2018
• Supplement Date Received by Manufacturer: 05/04/2018
• Initial Report FDA Received Date: 03/06/2018
• Supplement Report FDA Received Date: 05/18/2018
• 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: Required Intervention