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

Catalog Number ZSLE-13-90-ZT

Device Problem Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/31/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The reported device is not available for evaluation.Clinical interpretation of the event: based on the available information it is reasonable to suggest that the leading cause to this event might be associated with an eventual medical procedure / intervention / user technique inaccuracy or an eventual malfunction of the device.A document review was performed and no anomalies related to the event were noted.

Event Description

It was reported that during an abdominal aortic aneurysm repair, a zenith flex with spiral-z technology aaa endovascular graft iliac leg was inserted into the patient's right common iliac.The device deployed successfully.Upon putting in the coda and inflating the coda balloon, the graft ruptured in the middle at the spiral- z-stents.Due to the rupture, another zsle was implanted and successfully deployed.There was no unintended section of the device remaining inside the patient's body.The patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

510 (k) p020018.Investigation- a review of the complaint history, device history record, instructions for use, quality control, and trends was conducted during the investigation.Zenith flex with spiral-z technology aaa endovascular graft iliac leg (lot6976091) was not returned; therefore, device failure analysis and physical examination of the device used in this case could not be performed.A review of the device history record was performed and non-conformances were noted.A search of our complaint records indicated that there were no other complaints associated with the complaint lot number 6976091.Based on the investigation evaluation, there is no indication that the a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing and quality controls that may have contributed to this incident.Graft tearing or rupture can happen for several reasons including manufacturing imperfection, calcification wearing against the graft and excessive ballooning pressure.Due to the incidence happening during balloon inflation, and the lack of information provided the cause is most likely due to over inflation of the coda balloon.Based on the available information and the review of the documentation the root cause is likely product use of handling related ¿ user technique we will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 6682432
• MDR Text Key: 78895690
• Report Number: 1820334-2017-01417
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002552330
• UDI-Public: (01)10827002552330(17)190525(10)6976091
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ZSLE-13-90-ZT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2017
• Date Device Manufactured: 05/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 DA