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

Model Number	G35360
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Death (1802); Paraplegia (2448)
Type of Reportable Event	Death
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.Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: "patient died, cause of death unknown." additional information received 12jun2018: "patient expired on (b)(6) 2018." "patient experienced spinal shock from paraplegia, but this was not device-specific or related.The physician asserts that the procedure resulted in the paraplegia complication, and that it was not device specific or related." "product information: a) (b)(6) 2011 index tevar: zteg-2d-34-186-pf-us, lot e2463077----and zteg-2p-38-202-pf-us, lot e2776443.B) (b)(6) 2014 tevar (proximal extension for disease progression) zteg-2p-38-127-pf-us, lot e3078098" patient outcome: patient is deceased.
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.Summary of investigational findings: this complaint focuses on paraplegia which occurred after a secondary procedure performed to treat a separation between zteg-2d-34-186-pf-us (lot e2463077) and zteg-2p-38-202-pf-us (lot e2776443).As per clinical assessment of this event, the patient had a secondary intervention several years after index tevar to bridge and correct an endograft component (zteg 2p+2d) separation, causing endoleak type iii - most likely caused by disease progression.During the secondary intervention the endoleak type iii was sealed using a zta component, but at the same time any potential blood supply from the aneurysm sac to the spinal cord was blocked.The exact cause of the paraplegia could not be determined based on the provided information.It should be noted that the physician has not revealed or implied any information to raise concern about device malfunction or otherwise device related contributions to the event.In addition, paraplegia is a known inherent risk of this device addressed in the ifu as an adverse event.Cook medical will continue to monitor for similar events.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 7633028
• Report Number: 3002808486-2018-00726
• Device Sequence Number: 16699667
• Product Code: MIH
• UDI-Device Identifier: 10827002353609
• UDI-Public: (01)10827002353609(17)210122(10)E3678702
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/22/2021
• Device Model Number: G35360
• Device Catalogue Number: ZTA-P-38-217-W
• Device Lot Number: E3678702
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/07/2018
• Initial Date Received by Manufacturer: 06/06/2018
• Supplement Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 06/25/2018
• Supplement Report FDA Received Date: 11/27/2018
• 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: Death
• Patient Weight: 50