MAUDE Adverse Event Report: COOK INC ZENITH WITH Z-TRAK AAA ENDOVASCULAR GRAFT CONVERTER; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
A zenith with z-trak aaa endovascular graft converter was used for treatment of an iliac aneurysm.It was reported that the hemostatic valve leaked too much blood.A section of the device did not remain inside the patient¿s body.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
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.A review of manufacturing documentation in place at the time of manufacture was performed and revealed that the device is leak tested during qc.A review of the device history record determined no discrepancies related to the reported event were found.The product was not returned to aid in the investigation.However, possible causes for hemostatic valve leakage could be due to any tear in the disk due to insufficient silicone oil usage or due to the iris valve damage, which could be a manufacturing error or a procedural error in turning the lock too many times.No adverse effect on patient was noted due to this occurrence.Measures have been previously initiated to address this issue.We will notify the appropriate personnel and continue to monitor for similar complaints.

• Brand Name: ZENITH WITH Z-TRAK AAA ENDOVASCULAR GRAFT CONVERTER
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6898515
• Report Number: 1820334-2017-02885
• Device Sequence Number: 788253
• Product Code: MIH
• UDI-Device Identifier: 10827002551920
• UDI-Public: (01)10827002551920(17)180225(10)5668132
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2018

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: N/A
• Device Catalogue Number: ESC-28-12-80-ZT
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/15/2017
• Supplement Date Received by Manufacturer: 01/02/2018
• Initial Report FDA Received Date: 09/27/2017
• Supplement Report FDA Received Date: 01/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR