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 Problems Other (for use when an appropriate patient code cannot be identified) (2200); No Code Available (3191)

Event Date 06/04/2015

Event Type  Injury  

Event Description

A (b)(6) male patient in the spiral-z post-market registry (11-015) had a proximal type i endoleak at the 12-month follow up visit (387 days post procedure).The patient was being treated for an aortic aneurysm with a maximum aortic aneurysm diameter of 5.2 cm.The proximal neck had an inverted funnel shape with partial plaque/thrombus.The left iliac artery had moderate tortuosity, moderate calcification, and no occlusive disease.The right iliac artery had mild tortuosity, mild calcification, and mild occlusive disease.The patient received a cook bifurcated 24 mm x 96 mm main body device, a 20 mm x 56 mm left iliac leg device and a 24 mm x 56 mm right iliac leg device.No iliac leg extension were used.There was no difficulty deploying any of the components.A molding balloon was used but no details were provided regarding its use.A main body extension was placed below the rental arteries, but no other details were provided regarding the device.No additional procedures were performed.At the conclusion of the procedure, the devices were patent with no external compression, flow-limiting kinks, endoleaks or thrombus.On (b)(6) 2014 (30 days post procedure), the patient 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 (123 days post-procedure), the patient was seen in follow-up.The aneurysm had expanded by greater than 5mm.Devices were patent with no external compression, flow limiting kinks, thrombus, or migration.A type i proximal endoleak was noted.No further information regarding the case has been provided.

Manufacturer Narrative

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

Manufacturer Narrative

Lot # is unknown as no lot # was provided.Exp.Date unknown as no lot # was provided.Udi # is unknown as no lot # was provided.(b)(4).Device manufacture date: unknown as no lot # was provided.Event evaluation: the device was not returned; however, a review of complaint history and instructions for use (ifu) was conducted during the investigation.Lot number information was not provided; therefore, the device history record could not be reviewed.No medical imaging was provided about the event.There is no evidence to suggest that the product was not manufactured to the correct specifications.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 verification testing included water permeability testing, migration resistance testing, and radial force testing.The results met the acceptance criteria.The ifu provides instructions for use, contraindications, warnings and precautions regarding the appropriate method of use.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 is noted that the patient presented with an inverted funnel shaped neck.The ifu specifically states "key anatomical elements that may affect successful exclusion of the aneurysm include [.] an inverted funnel shape (greater than 10% increase in diameter over 15 mm of proximal aortic neck length).[.] in the presence of anatomical limitations, a longer neck may be required to obtain adequate sealing and fixation.Irregular calcification and/or plaque may compromise the attachment and sealing at the fixation sites.Necks exhibiting these key anatomical elements may be more conducive to graft migration or endoleak." based on the available information, it is possible that patient anatomy contributed to the event, as the patient presented with an inverted funnel shape neck and required placement of a main body extension during the initial implantation procedure.However, without additional information including patient imaging, a definitive root cause cannot be established.The appropriate internal personnel will be notified and we will continue to monitor for similar complaints.

Event Description

(b)(6) yr-old male patient in the (b)(6) post-market registry had a proximal type i endoleak at the 12-month follow up visit (387 days post-procedure).The patient was being treated for an aortic aneurysm with a maximum aortic aneurysm diameter of 5.2 cm.The proximal neck had an inverted funnel shape with partial plaque/thrombus.The left iliac artery had moderate tortuosity, moderate calcification, and no occlusive disease.The right iliac artery had mild tortuosity, mild calcification, and mild occlusive disease.The patient received a cook bifurcated 24 mm x 96 mm main body device, a 20 mm x 56 mm left iliac leg device and a 24 mm x 56 mm right iliac leg device.No iliac leg extensions were used.There was no difficulty deploying any of the components.A molding balloon was used but no details were provided regarding its use.A main body extension was placed below the renal arteries, but no other details were provided regarding the device.No additional procedures were performed.At the conclusion of the procedure, the devices were patent with no external compression, flow-limiting kinks, endoleaks or thrombus.On (b)(6) 2014 (30 days post procedure), the patient 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 (123 days post-procedure), the patient was seen in follow-up.The aneurysm had expanded by > 5 mm.Devices were patent with no external compression, flow limiting kinks, thrombus, or migration.A type i proximal endoleak was noted.No further information regarding the case has been provided.

• 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 ; 8123392235
• MDR Report Key: 4929265
• MDR Text Key: 15305063
• Report Number: 1820334-2015-00407
• 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: Study,Health Professional,health professional,stu
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/18/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/04/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/19/2015
• Initial Date FDA Received: 07/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/01/2015
• 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 Age: 72 YR