MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	ZTEG-2P-34-152-PF-US
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pseudoaneurysm (2605)
Date of Event	02/18/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) catalog#: zteg-2p-34-152-pf-us.Investigation is still in progress.
Event or Problem Description
Description of event according to study: on (b)(6) 2013, the patient received a zteg-2p-34-127-pf-us (lot # e3137095) and a zteg-2p-34-152-pf-us (lot # e2921561).There were no difficulties deploying the device.A molding balloon was not used.No patient-related adverse events were observed during the procedure.Per site, the device was patent with no kink or endoleak on the completion angiogram.The patient was discharged from the hospital on (b)(6) 2013 (six days post-procedure).On (b)(6) 2014 ct scan (34 days post-procedure): grafts patent, intact with no kink or endoleak.New pseudoaneurysms were present proximal and distal to the endograft margins.The proximal pseudoaneurysm eliminated the proximal sealing zone and the distal pseudoaneurysm shortened the distal sealing zone.Maximum aneurysm diameter = 50.1 mm.On (b)(6) 2015 ct scan (392 days post-procedure): grafts patent, intact with no migration or kink.A distal type i endoleak was noted.Maximum aneurysm diameter = 40.6 mm.On (b)(6) 2015 ct scan (740 days post-procedure): grafts patent, intact with no migration or kink.A distal type i endoleak was noted.Maximum aneurysm diameter = 47.7 mm.Patient outcome: on (b)(6) 2016 (792 days post-procedure), a secondary intervention was performed.No additional information is available at this time but will be added when it becomes available.
Additional Manufacturer Narrative
(b)(4).Summary of investigational findings: it was concluded that the most likely root cause for the type ib endoleak was that the length of the sealing zone was insufficient.The distal seal zone was abnormal at implantation.No evidence to suggest that the product was not manufactured according to specifications.Cook medical will continue to monitor for similar events.
Event or Problem Description
Description of event according to study: on (b)(6) 2013, the patient received a (b)(4) (lot # e3137095) and a (b)(4) (lot # e2921561).There were no difficulties deploying the device.A molding balloon was not used.No patient-related adverse events were observed during the procedure.Per site, the device was patent with no kink or endoleak on the completion angiogram.The patient was discharged from the hospital on (b)(6) 2013 (six days post-procedure).On (b)(6) 2014 ct scan (34 days post-procedure): grafts patent, intact with no kink or endoleak.New pseudoaneurysms were present proximal and distal to the endograft margins.The proximal pseudoaneurysm eliminated the proximal sealing zone and the distal pseudoaneurysm shortened the distal sealing zone.Maximum aneurysm diameter = 50.1 mm.(b)(6) 2015 ct scan (392 days post-procedure): grafts patent, intact with no migration or kink.A distal type i endoleak was noted.Maximum aneurysm diameter = 40.6 mm.(b)(6) 2015 ct scan (740 days post-procedure): grafts patent, intact with no migration or kink.A distal type i endoleak was noted.Maximum aneurysm diameter = 47.7 mm.Patient outcome: on (b)(6) 2016 (792 days post-procedure), a secondary intervention was performed.No additional information is available at this time but will be added when it becomes available.

• Brand Name: ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; 4632 bjaeverskov; DA
• MDR Report Key: 5488468
• Report Number: 3002808486-2016-00097
• Device Sequence Number: 445076
• Product Code: MIH
• UDI-Device Identifier: 10827002534282
• UDI-Public: (01)10827002534282(17)150522(10)E2921561
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P070016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2016

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 Catalogue Number: ZTEG-2P-34-152-PF-US
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2016
• Supplement Report FDA Received Date: 07/06/2016
• 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; Required Intervention
• Patient Age: 85 YR
• Patient Weight: 80