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	G55244
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/26/2017
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
As reported by the distributor, during an abdominal aortic aneurysm (aaa) repair on a (b)(6) male patient, the physician was unable to withdraw the mandrel from the delivery system of the zenith flex with spiral-z technology aaa endovascular graft iliac leg extension; even after numerous attempts.This graft was not implanted.It was reported that the procedure outcome was very good.According to the reporter, the patient did not experience any adverse effects due to this occurrence.No part of the device remained inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Additional information was provided on 02october2018 about the complaint issue.As advised, the initially reported "mandrel" meant ¿the shipping stylet¿.The shipping stylet could not be removed from the delivery system while the device was being prepped for the procedure.This complaint report was reassessed for reportability based on the new information received.Per the reassessment it was determined this event is not reportable.This event does not meet the criteria for a reportable event.The reported issue did not cause or contribute to a death or serious injury nor has this issue caused or contributed to a death or serious injury in the past.The device did not malfunction in a manner that would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur.No additional reports will be forthcoming related to this customer complaint.

• 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: 6859170
• Report Number: 1820334-2017-02288
• Device Sequence Number: 660164
• Product Code: MIH
• UDI-Device Identifier: 10827002552446
• UDI-Public: (01)10827002552446(17)200504(10)7858717
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2018

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: G55244
• Device Catalogue Number: ZSLE-24-39-ZT
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/29/2017
• Supplement Date Received by Manufacturer: 10/02/2017
• Initial Report FDA Received Date: 09/12/2017
• Supplement Report FDA Received Date: 04/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR