MAUDE Adverse Event Report: COOK INC ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number N/A

Device Problem Bent (1059)

Patient Problem No Code Available (3191)

Event Date 11/09/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Event is still under investigation at this time.

Event Description

An evar procedure was being performed on the (b)(6) year old male patient.When retrieving the top cap, the suprarenal stent got caught and bent.The user had to convert to an aui and used 2 additional devices to complete the procedure.No adverse consequence to the patient.

Manufacturer Narrative

A review of the device history record, documentation, instructions for use (ifu), manufacturing instructions, trends, and quality control data was conducted during the investigation.The complaint device was not returned; therefore no physical examination could be performed.However, a document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Tortuosity was present in the neck.A highly tortuous neck can cause the delivery system to press against one side of the suprarenal stent, despite the use of a stiff wire (i.E.Lunderquist), which was used.If the top cap was not properly docked or the pin vise not adequately tightened, there is potential for the resulting gap in the top cap / gray positioner transition to catch a suprarenal stent when retrieving the delivery system.Without further information, such as confirmation that the top cap was securely docked or imaging of the neck anatomy with the suprarenal stent deployed, it is impossible to definitively confirm a root cause.Therefore, a root cause of "procedure-related / patient condition-related "is listed as probable based on the testimony that the neck was tortuous.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

Event Description

It was reported that during an endovascular aneurysm repair (evar), while retrieving the top cap, the suprarenal stent got caught and bent.The user had to convert to a fem-fem bypass, using an aorto-uni-iliac device (aui) along with two additional devices to complete the procedure.The patient reportedly had tortuosity in the aortic neck.No adverse consequence to the patient was reported.

• Brand Name: ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6128995
• MDR Text Key: 60933366
• Report Number: 1820334-2016-01401
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002484228
• UDI-Public: (01)10827002484228(17)180726(10)7114588
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020018
• 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: 08/22/2017

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: TFFB-30-82-ZT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2016
• Initial Date FDA Received: 11/28/2016
• Supplement Dates Manufacturer Received: 08/14/2017
• Supplement Dates FDA Received: 08/22/2017
• Date Device Manufactured: 07/26/2016
• 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: 71 YR