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-30-140-PF-US
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) age/date of birth) unknown as information was not provided.Weight) unknown as information was not provided.Summary of investigational findings: based on the provided information and since no product was received it was not possible to determine whether the experienced issue is related to a device failure or user technique.However, wce has previously initiated corrective and preventing actions regarding this issue.The complaint device was manufactured prior to any actions, which perhaps may explain the experienced difficulty cook medical will continue to monitor for similar events.
Event or Problem Description
Description of event according to complainant: a (b)(6) female patient underwent a thoracic endovascular stent graft placement procedure for a thoracic aorta dissection from left subclavian to a few cm above celiac with small ulceration.During the procedure the physician deployed the graft and went to pull the trigger wire, the thumb screw came off fine but afterwards the green trigger wire release mechanism would not pull off; we were about to cut the wires and have him pull them that way after checking to see if there was some tension built up in the deployment system but after a few minutes he was able to finally tug the trigger wire release mechanism off without having to cut anything.The stent graft remained in the patient's body as intended but everything else was removed.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.

• 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: 5702747
• Report Number: 3002808486-2016-00377
• Device Sequence Number: 506586
• Product Code: MIH
• UDI-Device Identifier: 10827002534220
• UDI-Public: (01)10827002534220(17)170317(10)E3194407
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P070016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/05/2016

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 Catalogue Number: ZTEG-2P-30-140-PF-US
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2016
• Initial Report FDA Received Date: 06/07/2016
• 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: Other
• Patient Age: 64 YR