MAUDE Adverse Event Report: COOK INC ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

Catalog Number TFFB-28-96-ZT

Device Problem Leak/Splash (1354)

Patient Problem Other (for use when an appropriate patient code cannot be identified) (2200)

Event Date 03/03/2015

Event Type  Injury  

Event Description

The (b)(6) old male pt in the (b)(4) had an endoleak of unk type on (b)(6) 2015 (603 days post-procedure).The pt was treated on (b)(6) 2013 for an aortic aneurysm.The maximum aortic diameter was 56 mm.The proximal neck had a parallel shape with no plaque/thrombus.The left iliac artery had mild tortuosity, mild occlusive disease, and mild calcification.The pt received a main-body device, a left iliac leg, and a right iliac leg.There was no difficulty deploying any of the components.No other procedures were performed and no additional devices were used.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, endoleaks, or thrombus.On (b)(6) 2013 (74 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, migration or endoleaks.On (b)(6) 2015 (603 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 or migration.An endoleak of unk type was noted.

Manufacturer Narrative

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

Manufacturer Narrative

Pt outcome: on (b)(6) 2013 (74 days post procedure), the pt was seen in follow-up, no change in the size of the aneurysm.Devices were patent with no external compression, flow limiting kinks, thrombus, migration or endoleaks.On (b)(6) 2015 (603 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, or migration.An endoleak of unknown type was noted.Investigation- evaluation: based on the information provided, a pt in the spiral-z post-market registry underwent initial endovascular aortic repair (evar) in 2013 with placement of a main body graft and two spiral-z leg extension grafts.At 603 days post-implant, an endoleak of unknown type was observed.No intervention or adverse effect have been reported.The device has completed design control requirements demonstrating that the device meets the predetermined requirements and that the requirements meet the needs of the user.Specifically, these devices have been evaluated in clinical trials which assessed the occurrence of the endoleak.Design verification included radial force testing, migration resistance testing, and water permeability testing.The instructions for use pamphlet (ifu) provides the suggested instructions for use, warnings, and precautions for this device.Specifically, it states "additional endovascular interventions or conversion to standard open surgical repair following initial endovascular repair should be considered for pts experiencing an enlarging aneurysm, unacceptable decrease in fixation length (vessel and component overlap) and/or endoleak.An increase in aneurysm size and/or persistent endoleak or migration may lead to aneurysm rupture." the ifu also provides instructions on "key anatomical elements that may affect successful exclusion of the aneurysm." summary of investigation: limited information was provided regarding this complaint.No lot number, pt imaging, or pt anatomical factor information were provided.Without additional information, a definitive root cause cannot be established.The appropriate internal personnel have been notified and continued monitoring for similar events will be occur.

• Brand Name: ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
• Manufacturer (Section D): COOK INC; bloomington IN 47404
• Manufacturer Contact: larry pool, mgr ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4774948
• MDR Text Key: 5777934
• Report Number: 1820334-2015-00256
• 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: Foreign,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: TFFB-28-96-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: 03/03/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/20/2015
• Initial Date FDA Received: 05/12/2015
• 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: 80 YR