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	G55243
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/21/2017
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
It was reported during an initial endovascular abdominal aortic aneurysm repair (evar) procedure, the zenith flex with spiral-z technology aaa endovascular graft iliac leg, (b)(4) was difficult to deploy in the common iliac.The shift was impossible to get down on the positioner and it was impossible to deploy the graft.Another device was used to complete the procedure.The patient¿s anatomy was not tortuous.It was also reported that images will not be provided as the hospital is not permitted to provide information about the patient.There were no adverse effects to the patient due to this occurrence.
Additional Manufacturer Narrative
Additional information/clarification of event received on january 17, 2018.Investigation/evaluation: the zenith flex with spiral-z technology aaa endovascular graft iliac leg was not returned for an evaluation.Without the complaint device, a physical investigation was not able to be completed.A review of device history records, instructions for use, manufacturing instructions, and quality control data was conducted.Review of the device history record revealed that no non-conformances were noted.After receiving clarification of the event, it appears that the physician had difficulty retracting the main body sheath to deploy the device.No other information is given about the device.Retraction of the main body sheath can be difficult and requires enough force to overcome the frictional forces from the loaded graft.A bend or kink in the system was not noted by the customer.The customer stated that the patient did not have tortuous anatomy, making these possible causes unlikely.The ifu explains the flushing procedure for the device, which is necessary for air removal and to wet the graft.When the graft is wet, the frictional force is lessened, allowing the flexor sheath to be retracted easier.It was stated that the captor valve was open during the attempt to retract the flexor sheath.It is required that the captor valve is placed in the open position as stated in the ifu to enable the flexor sheath to be retracted.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.Do not bend or kink the delivery system.Doing so may cause damage to the delivery system and the zenith spiral-z aaa iliac leg graft.Do not continue advancing any portion of the delivery system if resistance is felt during advancement of the wire guide or delivery system.Stop and assess the cause of the resistance; vessel, catheter or graft damage may occur.Exercise particular care in areas of stenosis, intravascular thrombosis, or in calcified or tortuous vessels.Possible causes for facing deployment difficulties are: due to tortuous anatomy, any bend or kink in the delivery system (possibly due to continued advancement when resistance is encountered), or if the captor valve on the sheath is not turned to open position.The qc specification and design history files were reviewed and no evidence was found that the device was not manufactured to specification.Due to the lack of information, a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is warranted.The appropriate personnel have been notified of this event.Monitoring will continue to be performed for similar complaints.
Event or Problem Description
The physician had difficulty retracting the main body sheath and was unable to deploy the zenith flex with spiral-z technology aaa endovascular graft iliac leg.

• 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: 7140211
• Report Number: 1820334-2017-02061
• Device Sequence Number: 1472393
• Product Code: MIH
• UDI-Device Identifier: 10827002552439
• UDI-Public: (01)10827002552439(17)200817(10)8119548
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2018

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: G55243
• Device Catalogue Number: ZSLE-20-90-ZT
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/28/2017
• Supplement Date Received by Manufacturer: 03/05/2018
• Initial Report FDA Received Date: 12/21/2017
• Supplement Report FDA Received Date: 04/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 82