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

Catalog Number	ZTEG-2PT-40-208-PF-US
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer reference#: (b)(4).Introducer returned to manufacturer.Investigation is still in progress.
Event or Problem Description
Description of event according to complainant: upon deployment, it was very difficult to release the trigger wires.Wires were able to be released individually with hemostat.Due to manipulation required one of the nitinol wires broke.Ultimately, the procedure was successful and the device was placed in the patient.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
(b)(4).Summary of investigational findings: examination of the returned delivery system showed no marks or scratches on the green trigger wire knob.This indicates that the user has not been rotating the green trigger wire knob, which is consistent with the ifu.Rotation of the green trigger wire knob is probably not the reason for the difficulties.Microscopic examination of the trigger wires showed irregular black stains.This is highly likely due to inadequate coating on trigger wires.Based on the provided information and examination of the returned delivery system, it was possible to conclude that inadequate coating of trigger wires is the most likely reason for the difficulties regarding release of trigger wires.No evidence to suggest product was not manufactured to specifications cook medical will continue to monitor for similar events.
Event or Problem Description
Description of event according to complainant: upon deployment, it was very difficult to release the trigger wires.Wires were able to be released individually with hemostat.Due to manipulation required, one of the nitinol wires broke.Ultimately, the procedure was successful and the device was placed in the patient.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 TAPERED COMPONENT
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; 4632 bjaeverskov; DA
• MDR Report Key: 5684257
• Report Number: 3002808486-2016-00333
• Device Sequence Number: 280793
• Product Code: MIH
• UDI-Device Identifier: 10827002534510
• UDI-Public: (01)10827002534510(17)180225(10)E3306744
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P070016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2016

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-2PT-40-208-PF-US
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/27/2016
• Supplement Report FDA Received Date: 11/14/2016
• 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