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

Model Number	G55192
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The area representative reported that during preparation for an aortoiliac endovascular aneurysm repair (evar) procedure on a male patient, when the zenith with z-trak aaa endovascular graft converter was flushed, the fluid poured out of the back end of the captor valve.When this device was introduced into the patient, blood also started leaking from the valve.Once the graft was deployed the delivery system was removed and a 20fr sheath was inserted to replace it.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
Corrected data: report source.Investigation/evaluation: the product was returned for investigation.A review of complaint history, the device history record, documentation, instructions for use (ifu), manufacturing instructions and quality control data was conducted.The product was returned and a device failure analysis was performed.Water was injected into the system through the valve flushing port and fluid emerged immediately with little pressure.The device history record was reviewed, for 5409778 (finished assembly), sa5294975/sa5229814 (sheath assembly), and sa5126375/sa5098242 (captor valve assembly), noting no non-conformances related to the reported failure mode.A review of complaint history revealed that this is the only reported complaint associated to the complaint lot number.Each zenith device is shipped with instructions for use (ifu), listing the indications for use, contraindications, warnings and precautions, and the correct deployment procedure.Per the ifu: inspect the device and packaging to verify that no damage has occurred as a result of shipping.If damage has occurred, do not use the product and return to cook.It is important to monitor blood loss from the hemostatic valve throughout the procedure, but is specifically relevant during and after manipulation of the gray positioner.After the gray positioner has been removed, if blood loss is excessive, consider placing an uninflated molding balloon or an introduction system dilator within the valve, restricting flow.Based on the information provided and the device analysis, the root cause for the reported issue is manufacturing related.Measures have been initiated to address this failure mode.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.Appropriate personnel have been notified of this event.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

• 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: 7035601
• Report Number: 1820334-2017-03780
• Device Sequence Number: 19342091
• Product Code: MIH
• UDI-Device Identifier: 10827002551920
• UDI-Public: (01)10827002551920(17)171107(10)5409778
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2018

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: G55192
• Device Catalogue Number: ESC-28-12-80-ZT
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/06/2017
• Supplement Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 11/15/2017
• Supplement Report FDA Received Date: 03/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1