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	Delivery System Failure (2905)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was not possible to remove the stylet from introduction system.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
A review of the complaint history, drawings, dimensional verification, device history record, instructions for use (ifu), trends, quality control, and visual inspection of the returned device was conducted during the investigation.The device was returned for evaluation.Visual inspection noted the stylet wire to be partially removed from the proximal end of the delivery system and the stylet hub to be missing from the device.Several attempts to remove the wire both with forward and backward motion demonstrated that the wire did not move at all in either direction.All performed measurements were within specifications.A document-based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided and results of the investigation, a definitive root cause could not conclusively be determined.Per the quality engineering risk assessment, no further action is required.We will continue to monitor for similar complaints.
Event or Problem Description
It was reported that it was not possible to remove the stylet from introduction system for the zenith flex with spiral-z technology aaa endovascular graft iliac leg.There was no reported injury to the patient.No further information was provided.

• 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: 6043206
• Report Number: 1820334-2016-01077
• Device Sequence Number: 16499037
• Product Code: MIH
• UDI-Device Identifier: 10827002552354
• UDI-Public: (01)10827002552354(17)190228(10)6751521
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 07/12/2017

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-13-122-ZT
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/22/2016
• Supplement Date Received by Manufacturer: 06/29/2017
• Initial Report FDA Received Date: 10/20/2016
• Supplement Report FDA Received Date: 07/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1