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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a type 1b endoleak occurred on a right zenith flex with spiral-z technology aaa endovascular graft iliac leg during an endovascular aneurysm repair (evar) procedure.While ballooning with a competitor's balloon, it was noted that the distal end of the right iliac leg graft had a small possible type 1b endoleak.The physician ballooned again with a competitor's balloon, and caused a small rupture on the distal external side of the right iliac artery.There was slight plaque in the location of ballooning.It was noted the ballooning caused the rupture of the right iliac artery.There was no damage to the graft or leaking through the graft.The iliac rupture was repaired with the placement of an extension graft and a covered stent.This report captures the type 1b endoleak on the zenith iliac leg graft.No other adverse effects were reported for this incident.
Additional Manufacturer Narrative
This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Upon further review, it was determined the placement of an additional extension graft and covered stent treated the type 1b endoleak along with the iliac rupture.Therefore, this event is considered a serious injury.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown or unavailable.Investigation ¿ evaluation: (b)(6) center informed cook on 08feb2022 of an incident involving a zenith flex with spiral-z technology aaa endovascular graft iliac leg (rpn: zsle-20-74-zt, lot: 14154428).On (b)(6) 2022 an 80-year-old male patient underwent an evar (endovascular aneurysm repair) procedure.After placement of the complaint device, the physician was using a medtronic reliant balloon when it was noted a possible small leak at the end of the graft.The physician then used a boston scientific mustang balloon to balloon again.The site has confirmed that a rupture occurred with the ballooning of the medtronic reliant balloon in the right iliac limb (distal external side).The site also confirmed the rupture occurred as a result of ballooning with the medtronic balloon.The rep has confirmed there was no damage to the device itself and no leaking through the graft, it was outside of the graft where the rupture occurred.The site has stated there was some calcification at the location of the ballooning.It is unknown if the patient was prescribed any anticoagulant/antiplatelet after the procedure.The sales rep was present during the procedure.A zenith flex with spiral-z technology aaa endovascular graft iliac (zsle-13-56) leg was placed to extend the initial leg placed.The physician also placed an icast stent higher into the iliac.A final angiogram was completed, and the issue was resolved.Reviews of the documentation including the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions and quality control procedures of the device, were conducted during the investigation.The complaint device was not returned for evaluation; therefore, no physical examination could be conducted.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) for lot 14154428 and graft subassembly lot sa13910404 found no nonconformances that could have contributed to the reported failure mode.It should be noted that no other complaints have been associated with the final product lot number.Cook also reviewed product labeling.The product ifu, t_zaaasz_rev4 ¿zenith spiral-z aaa iliac leg with the z-track introduction system,¿ provides the following information to the user related to the reported failure mode: 4 warnings and precautions 4.1 general ¿ 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.Patients experiencing reduced blood flow through the graft limb and/or leaks may be required to undergo secondary interventions or surgical procedures.4.2 patient selection, treatment and follow-up zenith spiral-z iliac artery distal fixation site greater than 10 mm in length and 7.5-20 mm in diameter (measured outer wall to outer wall) is required.These sizing measurements are critical to the performance of the endovascular repair.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 16 french vascular introducer sheath.Vessels that are significantly calcified, occlusive, tortuous or "thrombus lined" may preclude placement of the endovascular graft and/or may increase the risk of embolization.A vascular conduit technique may be necessary to achieve success in some patients.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.4.3 pre-procedure measurement techniques and imaging lack of non-contrast ct imaging may result in failure to appreciate iliac or aortic calcification, which may preclude access or reliable device fixation and seal.After endovascular graft placement, patients should be regularly monitored for perigraft flow, aneurysm growth or changes in the structure or position of the endovascular graft.At a minimum, annual imaging is required, including: 1) abdominal radiographs to examine device integrity (separation between components or stent fracture) and 2) contrast and non-contrast ct to examine aneurysm changes, perigraft flow, patency, tortuosity, and progressive disease.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.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 appropriate procedural imaging is required to successfully position the zenith spiral-z aaa iliac leg and assure accurate apposition to the vessel wall.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 internal iliac arteries.4.6 molding balloon use use care in inflating the balloon within the graft in the presence of calcification, as excessive inflation may cause damage to the vessel.Confirm complete deflation of the balloon prior to repositioning.5.2 potential adverse events adverse events that may occur and/or require intervention include, but are not limited to: aortic damage, including perforation, dissection, bleeding, rupture and death endoleak endoprosthesis: improper component placement; incomplete component deployment; component migration; component separation from another graft component; suture break; occlusion; infection; stent fracture; graft material wear; dilatation; erosion; puncture; perigraft flow; and corrosion 8 patient counseling information all patients should be advised that endovascular treatment requires life-long, regular follow-up to assess their health and the performance of their endovascular graft.Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysms or changes in the structure or position of the endovascular graft) should receive enhanced follow-up.Specific follow-up guidelines are described in section 12, imaging guidelines and postoperative follow-up.10.5 device diameter sizing guidelines the choice of diameter should be determined from the outer wall to outer wall vessel diameter and not the lumen diameter.Undersizing or oversizing may result in incomplete sealing or compromised flow.11 directions for use anatomical requirements iliofemoral access vessel size and morphology (minimal thrombus, calcium and/or tortuosity) should be compatible with vascular access techniques and accessories.Arterial conduit techniques may be required.Pre-implant determinants verify from pre-implant planning that the correct device has been selected.Determinants include: 1.Femoral artery selection for introduction of the delivery system (i.E.,define respective contralateral and ipsilateral iliac arteries).2.Angulation of aortic neck, aneurysm and iliac arteries.3.Diameters of infrarenal aortic neck and distal iliac arteries.4.Length from the aortic bifurcation of a previously placed main body or renu from the zenith aaa endovascular graft family of products to the internal iliac arteries/attachment site(s).5.Aneurysm(s) extending into the iliac arteries may require special consideration in selecting a suitable graft/artery interface site.6.Degree of vascular calcification.11.1 zenith spiral-z aaa iliac leg system 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.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.Final angiogram 1.Position angiographic catheter just above the level of the renal arteries.Perform angiography to verify that the renal arteries are patent and that there are no endoleaks.Verify patency of internal iliac arteries.2.Confirm there are no endoleaks or kinks and verify position of proximal gold radiopaque markers.Remove the sheaths, wires and catheters.Note: if endoleaks or other problems are observed, refer to the suggested instructions for use for the zenith aaa endovascular graft ancillary components.12 imaging guidelines and postoperative follow-up 12.1 general all patients should be advised that endovascular treatment requires lifelong, regular follow-up to assess their health and the performance of their endovascular graft.Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysms or changes in the structure or position of the endovascular graft) should receive additional follow-up.Evidence provided by the complaint facility, device history record, complaint history, manufacturing documents, and verification testing, suggests that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.Based on the information provided, no returned product and the results of our investigation, a definitive cause of the failure could not be established.It is possible that the patient¿s condition, as it was reported that calcification was present at the ballooning site, contributed to the event.Endoleak is a known inherent risk of the device per ifu.The appropriate personnel have been notified.Per the risk assessment no further action is required.We 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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 13579661
• Report Number: 1820334-2022-00284
• Device Sequence Number: 5681128
• Product Code: MIH
• UDI-Device Identifier: 10827002552422
• UDI-Public: (01)10827002552422(17)240819(10)14154428
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2022

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: 08/19/2024
• Device Model Number: N/A
• Device Catalogue Number: ZSLE-20-74-ZT
• Device Lot Number: 14154428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2022
• Supplement Date Received by Manufacturer: 05/12/2022; 06/15/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 06/10/2022; 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOSTON SCIENTIFIC MUSTANG BALLOON; C-UDLMY-751J-190-PIG-RSC-ABRM-IHI-FST-A; MEDTRONIC RELIANT BALLOON; ZSLE-13-56-ZT, LOT# 13474017
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male