MAUDE Adverse Event Report: COOK INC ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow up report will be sent upon conclusion.
Event or Problem Description
It was reported that while prepping the device with heparinized saline for the endovascular aneurysm repair (evar) procedure the pa-c was unable to flush through the captor valve.The physician also attempted to flush the device without success.The medical team noticed that the captor valve had a slow leak at the clear part of the valve where it met with the grey ring.They were uncomfortable using the device for the procedure and instead exchanged it for a new device of the same size.The procedure was completed without issue.Of note, the complaint device never came into contact with the patient and was never deployed.No further information was provided.
Additional Manufacturer Narrative
Investigation/evaluation: a review of documentation was performed.This included a review of complaint history, the device history record, drawings, the instructions for use (ifu), manufacturing instructions, and quality control data.The zenith flex with spiral-z technology aaa endovascular graft iliac leg was returned for investigation.The entire delivery system was returned with the stent graft still sheathed and without original packaging.There were no signs of use or damage except for a permanent bend in the system due to transportation packaging.An attempt was made to flush the system using the captor valve luer extension and using a 30mm syringe.Excess pressure was used before fluid was observed.Fluid was noted from the delivery system in the order of the iris valve, pin vice, then the flushing groove.The evaluation revealed that there was leaking through the valve far before fluid emerged from the tip.The evaluation did not observe leakage through the valve housing as was reported that physician had observed.Flushing was achieved by inducing a large enough flow rate through the valve to match the pressure gradient in the system to the valve.The device history records were reviewed which included the finished assembly, sheath assembly and the captor valve assembly.Nonconformances on captor valve assembly were noted for staging error (reworked), failed leak check (scrapped), work order error (reworked), damaged web (scrapped), and failed leak test (scrapped).Each zenith device is shipped with instructions for use (ifu), listing the indications for use, contraindications, warnings and precautions, and the correct deployment procedure.The ifu advises, ¿do not use this device if damage has occurred as a result of shipping.If damage has occurred, do not use the product and return to cook." based on the investigation evaluation, a definitive root cause for the leakage could not be determined.Measures have been initiated to address this failure mode.Monitoring will continue to be performed for similar complaints.

• Brand Name: ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6564558
• Report Number: 1820334-2017-00878
• Device Sequence Number: 16427746
• Product Code: MIH
• UDI-Device Identifier: 10827002552330
• UDI-Public: (01)10827002552330(17)191205(10)7461549
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2017

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: ZSLE-13-90-ZT
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/17/2017
• Supplement Date Received by Manufacturer: 12/06/2017
• Initial Report FDA Received Date: 05/12/2017
• Supplement Report FDA Received Date: 12/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1