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

Model Number	N/A
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that during an endovascular aneurysm repair (evar) with right and left femoral access using a zenith with z-trak aaa endovascular graft converter, the sutures of the top stent were loose and that the graft was sliding down the stent strut.The evar was scheduled to repair aneurysm above previous open aortic aneurysm repair.The plan was to flip a convertor to seal in open graft in the abdominal aorta.We opened the graft on the back table and the plan was to flip it and put it back in the sheath.When we first opened the first esc (lot 5349451), it showed that the sutures of the top stent were loose and that the graft was sliding down the stent strut (captured in medwatch with number 1820334-2017-01510).The graft was thought to be expiring soon and perhaps that was the reason.Another graft was then opened that with an expiration date in 2018 (lot 6264283) and the same problem occurred (captured in medwatch with number 1820334-2017-01511).The doctor decided to add sutures to fix the problem before putting it back in the sheath.Issue was that the loose sutures affected the seal stent and therefore affected seal zone by decreasing the accuracy of the seal.The patient did not require any additional procedures due to this occurrence.There were no adverse effects on the patient due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, instructions for use, manufacturing instructions, and quality control data was conducted during the investigation.The complaint device was not returned; therefore, device failure analysis and physical examination of the device used in this case could not be performed.A document-based investigation evaluation showed no evidence to suggest the product was not made to specifications.Review of the 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.Images of the device were sent to assist the investigation.The images show the apices of the top stent being uncovered as the suture and graft slides along the strut.This failure mode can be caused by loose sutures, damaged sutures, placing acute force on the graft material between stent apices, or placing excessive opposing forces on the stent and graft simultaneously.The failure mode was found when the physician was flipping the device and attempting to re-sheath the device.Per the instructions for use: "do not attempt to re-sheath the graft after partial or complete deployment." it is possible that during re-sheathing ,opposing forces were applied to the stent and graft, causing the sutures to slide along the stent.Based on the provided information, no product returned, and the investigation, the most likely root cause may be related to product use or handling - modification after distribution.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

• 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: 6717065
• Report Number: 1820334-2017-01510
• Device Sequence Number: 16545286
• Product Code: MIH
• UDI-Device Identifier: 10827002551944
• UDI-Public: (01)10827002551944(17)171015(10)5349451
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 09/07/2017

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: ESC-36-12-82-ZT
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/19/2017
• Supplement Date Received by Manufacturer: 09/01/2017
• Initial Report FDA Received Date: 07/17/2017
• Supplement Report FDA Received Date: 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1