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

Catalog Number TFFB-26-111-ZT

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

Patient Problem Stroke (2086)

Event Date 05/08/2013

Event Type  Injury  

Event Description

This (b)(6) female patient in the (b)(4) registry experienced a stroke on (b)(6) 2013.The patient was being treated for a 6.8 cm aortic aneurysm.No other information is available regarding the stroke.The proximal neck had a parallel shape with no plaque/thrombus.The left iliac artery had mild tortuosity, no occlusive disease, and mild calcification.The right iliac artery had mild tortuosity, no occlusive disease, and mild calcification.The patient received a min-body device, a left iliac leg, and a right iliac leg.There was no difficulty deploying any of the components.An angioplasty was performed before the deploying any of the components.An angioplasty was performed before the deployment procedure in the native left iliac artery.Following the deployment procedure, iliac angioplasty was performed in the left leg/leg extension and one uncover stent was placed in the left leg/leg extension.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 (272 days post-procedure), the 1-6 mo clinical assessment was completed.The ct showed that the aneurysm had contracted by >5 mm in diameter.The devices were patent with no evidence of external compression, flow-limiting kin, thrombus, migration, or endoleak.

Manufacturer Narrative

(b)(4).Event is still under investigation.

Manufacturer Narrative

Event eval: a review of complaint history, instructions for use (ifu) and trends was conducted during the investigation.Based on the information provided, a patient in the (b)(6) registry suffered a stroke one day post-procedure.No patient outcome information was provided, although the patient was seen for the 1-6 mo clinical assessment 272 days post-procedure, and no adverse effects were noted.Additional information was requested but was not received.The zenith device has completed design control requirements demonstrating that the device meets the predetermined requirements and that the requirements meet the needs of the user.The ifu contains the instructions for use, contraindications, warnings and precautions regarding the appropriate method of use for this device.Specifically, it states "adverse events that may occur and/or require intervention include, but are not limited to -neurologic local or systemic complications and subsequent attendant problems (e.G., stroke, transient ischemic attack, paraplegia, paraparesis, paralysis)." based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event stroke is a documented adverse effect relating to endovascular aneurysm repair.The patient's pre-existing conditions and comorbidities were not provided.The physician should carefully consider for each patient the risks and benefits relating to endovascular repair and open surgical repair.The safety of the graft was evaluated in a clinical trial, which resulted an acceptable occurrence rate of neurologic complications.Without additional information, a definitive root cause cannot be established.However, this event was likely procedure related.Quality engineering assessed the risk.The risk remains acceptable with inclusion of this event.No additional risk reduction activities are required at this time.The appropriate internal personnel have been notified.We will continue to monitor for similar events.

• 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.; bloomington IN 47404
• Manufacturer Contact: rita harden, director ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4136246
• MDR Text Key: 4930962
• Report Number: 1820334-2014-00447
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 08/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: TFFB-26-111-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: 05/08/2013
• Event Location: Hospital
• Date Manufacturer Received: 08/21/2014
• 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: 68 YR