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

Catalog Number TFFB-26-96-ZT

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem Ischemia (1942)

Event Date 12/23/2014

Event Type  Injury  

Event Description

This (b)(6) year old male pt in the spiral-z post-market registry ((b)(4)) experienced clinical signs indicative of lower extremity ischemia on (b)(6) 2014 (83 days post-procedure).The pt was treated on (b)(6) 2014 for an aortoiliac aneurysm.The maximum aortic diameter was 6.0 cm.The proximal neck had a parallel shape with no plaque/thrombus.The bilateral iliac arteries had mild tortuosity, no occlusive disease, and mild calcification.The pt received a main-body device, a left iliac leg, a right iliac leg.There was no difficulty deploying any of the components.An occluder device was used during the procedure in an unspecified location.No other procedures were performed.A molding balloon was used but no details were provided regarding its use.At the conclusion of the procedure, the devices were patent with no external compression, flow-limiting kinks, or thrombus.A type ii endoleak was noted.On (b)(6) 2014 (37 days post-procedure), the pt was seen in follow-up.There had been no change in the size of the aneurysm.Devices were patent with no external compression, flow-limiting kinks, thrombus, endoleak or migration.On (b)(6) 2014 (83 days post-procedure), the pt experienced clinical signs indicative of lower extremity ischemia.No other info regarding the event is available.

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Manufacturer Narrative

Event evaluation: a review of the complaint history, instructions for use(ifu) and trends was conducted for the purpose of this investigation.The complaint device was not be returned for evaluation minimal information was provided to assist with this case.It is unclear where the ischemia occurred or if it was related to pre-existing anatomical conditions or use of the device.Therefore, a definitive root cause can not be determined or reported at this time.There is no evidence to suggest that the device was not manufactured to specification.Additional action is not required at this time the risk is insufficient per quality engineer risk assessment, the risk remains at an acceptable level as a result of this complaint.The appropriate internal personnel have been notified monitoring for similar complaints will continue.

• Brand Name: ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: larry pool, manager ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4452569
• MDR Text Key: 22264559
• Report Number: 1820334-2015-00060
• Device Sequence Number: 1
• Product Code: MIH
• 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: User Facility,user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: TFFB-26-96-ZT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/23/2014
• Device Age: NA
• Event Location: Hospital
• Date Manufacturer Received: 01/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 72 YR