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	05/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product received on - images were returned for review.Concomitant medical products: g55228, lot# 8428070; g32538, lot# ac1033658; g32551, lot# ac1033661, g55242, lot# 8687975.(b)(4) - the patient required a surgical intervention to preclude permanent impairment or death.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 reported that a (b)(6) year old male patient underwent a fenestrated endovascular aortic aneurysm repair (fevar) on (b)(6) 2019.The patient had a follow up ct scan on (b)(6) 2019 that showed a leakage at the bifurcation.They physician had the patient return for an angiogram on (b)(6) 2019.No invasive procedure were done at that time, however, a follow up procedure was scheduled for (b)(6) 2019.Per the ct scan, it appeared that there was a type iii endoleak at the bifurcation, however, this was to be confirmed on (b)(6) 2019.The physician and district manager would also confirm that the right limb graft is affected.Additional information in regards to the patient's second procedure was received on (b)(6) 2019.It was reported that the patient had a leak between the proximal and distal fenestrated pieces.Angiograms were performed and a reliant molding balloon was used in an attempt to fix the leak.The balloon was used between the proximal and distal fenestrated pieces, as well as down the limbs at the overlap of the distal body.The balloon was unsuccessful in repairing the leak, so an esbe-26-39-zt was placed to bridge the proximal and distal fenestrated pieces.The leak was successfully repaired.There were no adverse effects experienced by the patient due to this occurrence.Pre/post operative imaging is available.The anti-platelet or anti-coagulation therapy of the patient is currently unknown.There was no graft obstruction of high blood pressure within the graft during the endoleak.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged or unavailable.H6 - results code: leakage/seal - type iii endoleak was observed.Investigation - evaluation: a review of documentation including the device history record, complaint history, instructions for use (ifu) and quality control, as well as a visual inspection of imaging was conducted during the investigation.A visual inspection of imaging returned by the user facility for review was completed.Implantation angiography, post implantation portable chest x-ray, diagnostic angiography including one ultrasound image for access, two-months post implantation, and secondary intervention angiography one week later were provided along with the complaint report.The complaint of a type iii endoleak six weeks post implantation involving the zsle-11-107-zt could not be confirmed, as this endoleak could not be observed with the imaging provided.Additionally, a document-based investigation evaluation was performed.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.There is no evidence to suggest that product was not manufactured to current specifications.Design verification and validation testing demonstrated that the product is safe and effective for its intended use.A review of the device history record for lot 8428070 found no related nonconformances that could have contributed to the reported failure mode.A database search found this to be the only event associated with the device lot.Consequently, cook has concluded that there is no evidence that nonconforming product exists in house or in field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: ¿4.2 patient selection, treatment and follow-up -- zenith spiral-z iliac artery distal fixation site greater than 10mm in length and 7.5-20mm in diameter (measured outer wall to outer wall) is required.These sizing measurements are critical to the performance of the endovascular repair.-- for sizing requirements and a list of key anatomical elements that may affect successful aneurysm exclusion using a main body or renu from the zenith aaa endovascular graft family of products, refer to the appropriate instructions for use.4.2 patient selection, treatment and follow-up.-- zenith spiral-z iliac artery distal fixation site greater than 10mm in length and 7.5-20mm in diameter (measured outer wall to outer wall) is required.These sizing measurements are critical to the performance of the endovascular repair.-- for sizing requirements and a list of key anatomical elements that may affect successful aneurysm exclusion using a main body or renu from the zenith aaa endovascular graft family of products, refer to the appropriate instructions for use.-- adequate iliac or femoral access is required to introduce the device into the vasculature.Access vessel diameter (measured inner wall to inner wall) and morphology (minimal tortuosity, occlusive disease and/or calcification) should be compatible with vascular access techniques and delivery systems of a 14 french to 17 french vascular introducer sheath.Vessels that are significantly calcified, occlusive, tortuous or thrombus-lined may preclude placement of the endovascular graft and/or increase the risk of embolization.A vascular conduit technique may be necessary to achieve success in some patients.-- all patients should be monitored closely and checked periodically for a change in the condition of their disease and the integrity of the endoprosthesis and/or increase the risk of embolization.A vascular conduit technique may be necessary to achieve success in some patients.-- all patients should be monitored closely and checked periodically for a change in the condition of their disease and the integrity of the endoprosthesis.-- the zenith spiral-z aaa iliac leg has not been explicitly evaluated clinically; however, its performance is represented by the zenith aaa endovascular graft iliac leg (a previous version of the device), which has not been evaluated in the folling patient populations: - key anatomical elements that fall outside the sizing requirements specified in the appropriate main body or renu instructions for use -- successful patient selection requires specific imaging and accurate measurements; please see section 4.3, pre-procedure measurement techniques and imaging diameters -- utilizing ct, diameter measurements should be determined from the outer wall to outer wall vessel diameter (not lumen measurement) to help with proper device sizing and device selection.4.4 device selection -- strict adherence to the zenith spiral-z aaa iliac leg ifu sizing guide is strongly recommended when selecting the appropriate device size (table 10.5.1).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.4.5 implant procedure -- inaccurate placement and/or incomplete sealing of the zenith flex aaa endovascular graft within the vessel may result in increased risk of endoleak, migration or inadvertent occlusion of the renal or internal iliac arteries.-- inadequate fixation of the zenith flex aaa endovascular graft may result in increased risk of migration of the stent graft.Incorrect deployment or migration of the endorposthesis may require surgical intervention.11.1.7 molding balloon insertion 5.Expand the molding balloon with diluted contrast media (as directed by the manufacturer) in the area of the most proximal covered stent and the infrarenal neck, starting proximally and working in the distal direction.(fig.15) 6.Withdraw the molding balloon to the ipsilateral limb overlap region and expand.7.Withdraw the molding balloon to the ipsilateral distal fixation site and expand.8.Deflate and remove molding balloon.Transfer molding balloon onto the contralateral wire guide and into the contralateral iliac leg introduction system.Advance molding balloon to the contralateral limb overlap and expand.9.Withdraw the molding balloon to the contralateral iliac leg/vessel distal fixation site and expand.(fig.15) 10.Remove molding balloon and replace it with an angiographic catheter to perform completion angiograms.12.3 abdominal radiographs -- the following views are required: - four films: supine-frontal (ap), cross-table lateral, 30 degree lpo and 30 degree rpo views centered on umbilicus.- record the table-to-film distance and use the same distance at each subsequent examination -- ensure entire device is captured on each single image format lengthwise.-- if there is any concern about the device integrity (e.G.Kinking, stent breaks, barb separation, relative component migration), it is recommended to use magnified views.The attending physician should evaluate film for device integrity (entire device length including components) using 2-3x magnification visual aid.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, =5 mm of maximum diameter (regardless of endoleak status) - migration - inadequate seal length -- consideration for reintervention 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 reinterventions including catheter based and open surgical conversion are possible following endograft placement.¿ cook also reviewed product labeling for the esbe, endostent body extension.The product instructions for use (ifu) (t_eaaa36_rev3) states the following in consideration of the reported failure mode: "11 directions for use: 11.2 main body extension -- main body extensions (fig.2) are used for extending the proximal body of an in situ endovascular graft." based on the information provided, examination of imagery, and the results of our investigation, a definitive root cause could not be established.The most likely contributing factor can be attributed to patient anatomy (i.E.Severe tortuosity and disease progression) or procedural-related (i.E.Inadequate balloon expansion of the sealing stents at the overlap region).Severe tortuosity can result in a component separation endoleak due to the high degree of angulation of the bends within vessels.Disease progression can also result in loss of seal zone integrity between two interfacing components due to the gradual expansion of the vessel outer diameter over time.And lastly, inadequate balloon expansion (either over-ballooning or under-ballooning) can also result in the type iii endoleaks mentioned.Over-ballooning can potentially cause undue stretching of suture holes resulting in a type iiib endoleak; whereas, under-ballooning can potentially cause the overlap to be inadequately sealed resulting in type iiia component separation endoleak.Endoleak has been identified as a known inherent risk of the device.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.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.

• 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: 8759750
• Report Number: 1820334-2019-01610
• Device Sequence Number: 16718350
• Product Code: MIH
• UDI-Device Identifier: 10827002552286
• UDI-Public: (01)10827002552286(17)201222(10)8428070
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2019

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: 12/22/2020
• Device Model Number: N/A
• Device Catalogue Number: ZSLE-11-107-ZT
• Device Lot Number: 8428070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 10/29/2019
• 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: 67 YR