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

Model Number	G35329
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Thrombus (2101); Vascular Dissection (3160)
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 initial procedure went great.At the one month follow up, everything was fine.At six months the patient presented with leg weakness and a six month follow up ct scan was conducted.The scan revealed an issue just beyond the distal edge of the graft.They suspect this issue is either a dissection or circumferential thrombus formation.Patient outcome: they are planning a secondary intervention to re-line and extend the existing graft.
Additional Manufacturer Narrative
(b)(4).Summary of investigational findings: partially circumferential redundant fabric was the result of stent body crowding along the inner aortic curvature.A circumferential ridge of low density just distal to the endograft end most likely represents infolded redundant aorta as the intercostal arteries indicate inferior shift of the aorta through the endografted segment.Superimposed is thrombus beginning at a ridge of redundant fabric along the inner aortic curvature extending over the length of the distal mainbody stent to the redundant aorta.This merges with irregular thrombus that accumulated at the aortic ridge.The irregular thrombus trails downstream in the thoracic aorta.It is possible that the reported leg weakness was secondary to emboli liberated from this thrombus.A dissection was not present.The endograft diameter matched the aorta diameter proximally and was less than 10% oversized distally.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: the initial procedure went great.At the one month follow up, everything was fine.At six months the patient presented with leg weakness and a six month follow up ct scan was conducted.The scan revealed an issue just beyond the distal edge of the graft.They suspect this issue is either a dissection or circumferential thrombus formation.Patient outcome: they are planning a secondary intervention to re-line and extend the existing graft.
Additional Manufacturer Narrative
Exemption number e2016032.(b)(4).Name and address for importer site: (b)(4).Summary of investigational findings: partially circumferential redundant fabric was the result of stent body crowding along the inner aortic curvature a circumferential ridge of low density just distal to the endograft end most likely represents infolded redundant aorta as the intercostal arteries indicate inferior shift of the aorta through the endografted segment.Superimposed is thrombus beginning at a ridge of redundant fabric along the inner aortic curvature extending over the length of the distal mainbody stent to the redundant aorta.This merges with irregular thrombus that accumulated at the aortic ridge.The irregular thrombus trails downstream in the thoracic aorta.It is possible that the reported leg weakness was secondary to emboli liberated from this thrombus.A dissection was not present.The endograft diameter matched the aorta diameter proximally and was less than 10% oversized distally.Recall was initiated as indication for use for btai has been removed from the product labeling.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: 6095307
• Report Number: 3002808486-2016-01377
• Device Sequence Number: 1168956
• Product Code: MIH
• UDI-Device Identifier: 10827002353296
• UDI-Public: (01)10827002353296(17)181217(10)E3397339
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2016

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 Model Number: G35329
• Device Catalogue Number: ZTA-P-20-105-W
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/03/2016
• Initial Date Received by Manufacturer: 11/04/2016
• Supplement Date Received by Manufacturer: Not provided; 11/04/2016
• Initial Report FDA Received Date: 11/11/2016
• Supplement Report FDA Received Date: 03/21/2017; 09/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2099-2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention