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 Leak/Splash (1354)

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

Event Type  Injury  

Event Description

On a unk date, the physician suspected a type 3 endoleak in the right lateral aspect of the main body graft on a (b)(6) year old male pt.The pt had previously a evar (endovascular aortic repair) performed on 04/27/2010.Pt outcome has been requested, but it was not available at the time of the report.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).Event evaluation: a review of complaint history, instructions for use (ifu), quality control, specifications, and trends was conducted.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.Specifically, design validation testing has been conducted including a clinical trial in which the occurrence of endoleak was assessed.Additionally, design verification testing included water permeability testing and fatigue testing.There is no evidence to suggest the product was not manufactured to current specifications.The ifu contains the instructions for use, contraindications, warnings and precautions for appropriate use of this device.Specifically, it states "additional endovascular interventions or conversion to standard open surgical repair following initial endovascular repair should be considered for patients 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.Patients experiencing reduced blood flow through the graft limb and/or leaks may be required to undergo secondary interventions or surgical procedures." additionally, it states "the zenith flex aaa endovascular graft with the z-trak introduction system is indicated for the endovascular treatment of patients with abodominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair, including: -non-aneurysmal infrarenal aortic segment (neck) proximal to the aneurysm with a length of at least 15 mm".Imaging was received for this case and was forwarded for expert clinical review.Two multiphase ctas were provided.The first cta performed (b)(6) 2014 demonstrates prior zenith exclusion.The ima had been embolized and the original 5 mm zenith proximal seal zone extended with an unknown extension.The extension extended over the left renal artery ostium.Left renal artery patency was maintained with a chimney stent.The right renal artery was also stented.The endoleak had the greatest density along the right aspect of the main body and extended to the right l2 lumbar artery.The contrast density was greatest 4 mm superior the extension inferior margin, at a point where two layers of fabric were present.The second cta was performed (b)(6) 2015 after glue sac embolization.The sac had enlarged from 69 mm to 72 mm.Glue distribution and amount was consistent with either sac catheterization through the left limb seal zone or direct sac puncture.A large amount of glue was present in the location of the previous endoleak and extended to the right l2 lumbar artery ostium but not into the artery.Endoleak in the arterial phase was present posterior to the flow divider stent.If any endoleak was present in the original location, it was obscured by the glue streak artifact.In summary, the provided imaging suggests a type 3 endoleak through the main body as endoleak and aneurysm growth persisted despite prior treatments (ima coil embolization and proximal seal zone extension).The type 3 endoleak diagnosis is also uncertain as the 2014 cta suggests an endoleak that would have to occur around the extension end and then through the sealing stent, which is improbable but not impossible.A new endoleak precipitated by the prior intervention and obscured by the glue and persistent l2 lumbar artery endoleak also remain as possible explanations.Based on the review of the returned imaging, the endoleak is likely a type 3, although other possibilities cannot be ruled out.Based on the information provided, a cause for the type 3 endoleak cannot be determined.The risk was assessed using quality engineering risk assessment.The risk remains acceptable with inclusion of this event.No additional risk reduction activities are required.The appropriate internal personnel have been notified.We will continue to monitor for similar events.

Event Description

On an unknown date, the physician suspected a type 3 endoleak in the right lateral aspect of the main body graft on a (b)(6) male patient.The patient had previously a evar (endovascular aortic repair) performed on (b)(6) 2010.Patient outcome has been requested, but it was not available at the time of this report.

• 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: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 4774947
• MDR Text Key: 5800823
• Report Number: 1820334-2015-00307
• Device Sequence Number: 1
• Product Code: MIH
• 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,company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/21/2015

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 Model Number: N/A
• Device Catalogue Number: TFFB-24-96-ZT
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: NA
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/24/2015
• 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: 64 YR