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	G55231
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: custom made fenestrated/branched device (aaa-fen-bifurcated-graft; lot # ac999141); custom made fenestrated/branched device (fenestrated-pararenal-device; lot # ae49245 ¿ component lot numbers: ae49245 and ac999141); right iliac leg graft (zsle-13-56-zt; lot # 7071521); left iliac leg graft (zsle-13-56-zt; lot # 8050175); left renal stent (85341; lot # not provided-non-cook device).(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 reported that a (b)(6) male patient had a type i distal endoleak on the right iliac limb 12 months after the initial endovascular abdominal aneurysm repair.Pre-procedure imaging analysis ((b)(6) 2017) revealed a stable 51 mm juxtarenal aneurysm with no iliac angulation.All branch vessels were patent.On (b)(6) 2017 during the index procedure, the following devices were implanted.Custom made fenestrated/branched device (aaa-fen-bifurcated-graft; lot # ac999141); custom made fenestrated/branched device (fenestrated-pararenal-device; lot # ae49245 ¿ component lot numbers: ae49245 and ac999141); right iliac leg graft (zsle-13-56-zt; lot # 7071521); left iliac leg graft (zsle-13-56-zt; lot # 8050175); left renal stent (85341; lot # not provided-non-cook device).There were no difficulties deploying the stents during the initial procedure.Post procedure imaging revealed that no endoleaks were present and that there were no device integrity issues.The 30-day post-procedure ct ((b)(6) 2017) revealed a type ii (vessel perfusion endoleak).There was no component separation, migration, or device integrity issues.Branch vessels were patent.The 6-month post-procedure ct ((b)(6) 2018) revealed a type ii (vessel perfusion endoleak).Devices were patent.No separation, migration, or device integrity issues.The 12-month post-procedure ct ((b)(6) 2018) revealed the presence of a type i distal endoleak (right iliac leg graft).There was no separation of components, migration or device integrity issues.As of this submission, no treatment was provided.The patient remains in the study.
Event or Problem Description
There has been no new event information received since the last report was filed.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation/evaluation: the device was not available for evaluation.A document based investigation has been performed including a review of the device history records, instructions for use, and quality control data.A review of the device history records (dhr) revealed no non-conformances that would have caused or contributed the reported type ib endoleak at the distal seal site.Cook was unable to perform a physical evaluation of the complaint device as the product was not returned; the device remains implanted in the patient.Imaging was not collected in this post-market french reimbursement study; therefore, there is no imaging able to be reviewed.However, it was communicated that on the 12-month post-operative ct regular follow-up the type ib (distal) endoleak was discovered, and no treatment was provided.Per the instructions for use (ifu), additional surveillance and possible treatment is recommended for¿aneurysms with type i endoleak.The product instructions for use (ifu) (t_zaaasz_rev2) states the following in consideration of 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 following 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.There was not enough evidence to confirm the complaint based on the methods of analysis as the complaint device was not returned for evaluation, imaging was not provided, nor was a planning and sizing sheet supplied.As a result, a definitive investigation conclusion could not be determined.Based on current information in the clinical assessment, related causes such a human anatomy, medical procedure, device failure, user technique and/or manufacturing cannot be ruled out.However, the most likely contributing factors are either due to patient's anatomy or disease progression.A definitive conclusion could not be determined.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.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.

• 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: 8371257
• Report Number: 1820334-2019-00514
• Device Sequence Number: 1733723
• Product Code: MIH
• UDI-Device Identifier: 10827002552316
• UDI-Public: (01)10827002552316(17)190705(10)7071521
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/05/2019
• Device Model Number: G55231
• Device Catalogue Number: ZSLE-13-56-ZT
• Device Lot Number: 7071521
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2019
• Supplement Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 02/26/2019
• Supplement Report FDA Received Date: 04/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 52