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

Model Number	G35367
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2018
Type of Reportable Event	Malfunction
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: they put the device in the patient and decided they wanted a longer piece and took it out.They thought it would be good to use the device as a teaching opportunity.The physician deployed product on the back table.After all trigger wires were removed, the device remained constrained.There was a suture that should pre-form; however, it did not expand.It was constrained.Patient outcome: the patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Exemption number e2016032.(b)(4).Summary of investigational findings: the complaint states that the zta-p-42-173-w device was introduced into the patient, but was removed again because another size was desired.The device was afterwards deployed outside of the patient (for teaching purpose) and the wires were removed but the stent graft was constrained.The complaint stent graft was returned fully expanded.The investigation of the stents and the sutures showed no signs of damage.As the stent graft was introduced into the patient, withdrawn and then deployed outside the patient, it is possible that blood might have clotted inside the sheath and restricted the expansion of the stent graft.However, images of the constrained stent graft are not provided, information about the deployment procedure is limited and since the stent graft was returned expanded, it would be inappropriate to speculate at what may or may not have caused the stent graft to be constrained.Cook medical will reopen the investigation if further information is received.No evidence to suggest that the device was not manufactured according to specifications.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: 7315672
• Report Number: 3002808486-2018-00308
• Device Sequence Number: 1424184
• Product Code: MIH
• UDI-Device Identifier: 10827002353678
• UDI-Public: (01)10827002353678(17)200703(10)E3602387
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: G35367
• Device Catalogue Number: ZTA-P-42-173-W
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/21/2018
• Device Age: 7 MO
• Initial Date Received by Manufacturer: 02/20/2018
• Supplement Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 03/06/2018
• Supplement Report FDA Received Date: 06/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR