MAUDE Adverse Event Report: COOK INC ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was initially reported the patient had type 2 and type ib endoleaks post endovascular aneurysm repair (evar).An attempt to treat the endoleaks with coils was unsuccessful, as the leaks were unable to be resolved.The zalb-24-98 lot: 3542292, zsle-16-56-zt lot: 4253211, and zsle-20-56-zt lot: 2850440 were explanted.Additional information was received 12apr2019.Ballooning was performed in the usual places, the aortic neck, overlap and distal seal zones.The patient was taking aspirin as anti-coagulation therapy.Because of the expanding abdominal aortic aneurysm (aaa) due to the unresolved endoleaks, the evar grafts were explanted on (b)(6) 2019.The patient did fine post explant and was discharged home.This report captures the zsle-16-56-zt and zsle-20-56-zt type ib endoleaks.A report is not being filed for the zalb-24-98 endoleak, as this device is not sold in the us and there is not a similar device manufactured by cook inc.That is marketed in the us.
Additional Manufacturer Narrative
Investigation/evaluation: the devices were explanted but they were not returned evaluation.Imaging was provided for review.A document based investigation has been performed including a review of the provided imaging, device history record, instructions for use, manufacturing instructions, quality control data, and specifications.The complaints involve type ii and type ib endoleaks related to a zsle-16-56-zt and a zsle-20-56-zt.The devices were not returned.There is no representative device available because there are too many unrelated factors that prevent a true comparison between one device and another.First, these devices are a one device lot.In addition, it is not reasonable to tie two cases together where there are differences in patient medical history, patient anatomy and physician.Imaging review was completed.Two ctas were provided.The first was a non-contrast ct dated 5/15/18 followed by a cta on 5/23/18.The first ct was a non-contrast surveillance ct.The cta was performed to evaluate for endoleak after the non-contrast cta had demonstrated aneurysm growth.Embolization coils were absent.The absence of a type ib endoleak or type ill endoleak is supported by the report of attempted but failed coil embolization but omission of a reported type ib or type ill intervention.Because coils were absent, the intervention was performed after the provided cta.Per the customer, the abdominal aortic aneurysm (aaa) was expanding due to unresolved endoleaks.There is no evidence of any device kinking or infolding or compression.There is no mention of any difficulties occurring during the implantation.It is not known how long the endoleaks had been present or when the endoleaks were initially noticed.There is no information surrounding patient¿s compliance with follow up and no patient medical history was provided.The relevant findings of the image reviewer include: 1.The large aaa and scan sequence confirm aneurysm growth despite lack of a comparison ct.2.Type ii endoleak is confirmed of the zalb-24-98.3.Although a common iliac artery (cia) aneurysm permitted mural thrombus and blood flow outside the left zsle-20-56 stent, because the zsle still provided a 15mm seal zone, a type ib endoleak was not confirmed.The cia aneurysm was not caused by the abdominal aortic aneurysm (aaa) but was intrinsic to the left cia.A review of the device history records (dhr) for the final assembly and graft subassembly records revealed no non-conformances.The instructions for use (ifu) states the following in consideration of the reported failure mode: indications for use: the zenith spiral-z aaa iliac leg with the z-trak introduction system is indicated for use with the zenith aaa endovascular graft family of products, including the zenith flex aaa endovascular graft, zenith alpha abdominal endovascular graft, zenith low profile aaa endovascular graft, zenith renu ancillary graft, zenith fenestrated aaa endovascular graft, zenith universal distal body endovascular graft, zenith flex aui, or zenith branch iliac endovascular graft, during either a primary or a secondary procedure in patients who have adequate iliac/femoral access compatible with the required introduction systems.The graft is used in combination with these products for the endovascular treatment of abdominal aortic and aorto-iliac aneurysms.Warnings and precautions: additional endovascular interventions or conversion to standard open surgical repair following initial endovascular repair should be considered for patients experiencing enlarging aneurysms, 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.Multiple large, patent lumbar arteries, mural thrombus and a patent inferior mesenteric artery may all predispose a patient to type ii endoleaks.Patients with uncorrectable coagulopathy may also have an increased risk of type ii endoleak or bleeding complications.Strict adherence to the zenith spiral-z aaa iliac leg ifu sizing guide is strongly recommended when selecting the appropriate device size.Appropriate device oversizing has been incorporated into the ifu sizing guide.Sizing outside of this range can result in endoleak, fracture, migration, device infolding or compression.Inaccurate placement and/or incomplete sealing of the zenith spiral-z aaa iliac leg within the vessel may result in increased risk of endoleak, migration or inadvertent occlusion of the renal or internal iliac arteries.Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysm or changes in the structure or position of the endovascular graft) should receive enhanced follow-up.5.2 potential adverse events: aneurysm enlargement, aneurysm rupture and death, endoleak, surgical conversion to open repair.Directions for use: section 11.1.7: ipsilateral iliac leg placement and deployment.2.Confirm there are no endoleaks or kinks and verify position of proximal gold radiopaque markers.Remove the sheaths, wires and catheters.Imaging guidelines and postoperative follow-up: 12.6 additional surveillance and treatment: additional surveillance and possible treatment is recommended for: aneurysms with type i endoleak.Aneurysms with type iii endoleak.Aneurysm enlargement, =5mm of maximum diameter (regardless of endoleak status).Migration.Inadequate seal length.Consideration for re-intervention or conversion to open repair should include the attending physician¿s assessment of an individual patient¿s co-morbidities, life expectancy and the patient¿s personal choices.Patients should be counseled that subsequent re-interventions including catheter based and open surgical conversion are possible following endograft placement.There is no evidence to suggest these devices were not manufactured to specification.No type i or type ii endoleaks were noted on imaging review of the right zsle leg (zsle-16-56-zt).No defect was noted.A type 2 endoleak of the zalb-24-98 was confirmed via image review.However, type 2 endoleaks are due to patient anatomy and are not a graft failure.Based on customer testimony, a left zsle-20-56-zt type 1b endoleak was present.The image review did not confirm any type 1b endoleaks.The reported type ib endoleak likely occurred after the date of the ct imaging provided.Endoleak is a known inherent risk of this device.Cook has concluded human anatomy and disease progression contributed to this incident.A quality engineer risk assessment was conducted to assess the risk of this failure mode and concluded a change is not required, thus no risk reduction activities are required at this time.Cook will continue to monitor for similar complaints.The appropriate personnel have been notified of this event.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
There is no new event information to report.

• Brand Name: ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8541256
• Report Number: 1820334-2019-00520
• Device Sequence Number: 18910466
• Product Code: MIH
• UDI-Device Identifier: 10827002552378
• UDI-Public: (01)10827002552378(17)160501(10)4253211
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2016
• Device Model Number: N/A
• Device Catalogue Number: ZSLE-16-56-ZT
• Device Lot Number: 4253211
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 04/23/2019
• Supplement Report FDA Received Date: 05/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR