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
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Codes	Death (1802); Ischemia (1942); No Code Available (3191)
Date of Event	07/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: two zenith flex with spiral-z technology aaa endovascular graft iliac legs, rpns: zsle-9-122-zt and zsle-9-107-zt.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 a zenith flex aaa endovascular graft bifurcated main body had occluded 3 weeks after implant.The main body and 2 limbs (zenith flex with spiral-z technology aaa endovascular graft iliac legs) were implanted in (b)(6) year old a male patient on (b)(6) 2018.After the main body occluded, the patient developed bilateral leg ischemia and required amputations.They were discharged a week after the amputations ((b)(6) 2018).The patient has not followed up in the hospital's system since being discharged.The patient has since passed away, but it is unknown if cause of death is related to the cook devices.Date of death is unknown.Additional information has been requested regarding details about the occlusions and patient death but are currently unavailable.
Event or Problem Description
No additional patient/event information 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.H6 method code: (4114) device not returned.H6 patient code: no code available (3191) - the patient required amputations.Investigation evaluation.The complainant, (b)(6) health system located in the united states, informed cook on 01oct2019 via a device tracking form that three zenith aaa grafts were implanted in a patient during an endovascular aortic repair (evar) procedure on (b)(6) 2018.On (b)(6) 2019, cook received an updated copy of the device tracking form with information on the form indicating the patient was deceased.After follow-up by the sales representative with the customer, it was reported that the patient¿s graft, a zenith flex aaa endovascular graft main body with rpn tffb-22-82-zt from lot 8572383, had ¿occluded three weeks after implant¿.The patient had a normal size aorta and very large bilateral common iliac aneurysms as well as diffuse external iliac arteries and infrainguinal peripheral arterial disease.After the initial evar, the patient developed bilateral leg ischemia requiring amputations.The amputation procedure took place on (b)(6) 2018.The patient did not follow up within their health care system after discharge.The patient died on an unknown date and the cause of death is unknown.No additional information was provided regarding the initial evar, except that the graft was not altered prior to implant.No preoperative, intraoperative, or postoperative imaging was provided by the customer.A review of the complaint history, device history record, drawing, instructions for use (ifu), quality control and specifications of the device was conducted during the investigation.The visual inspection of the complaint device could not be completed as the device was not returned for investigation.No imaging was provided.Additionally, a document based investigation evaluation was performed.A review of the device master record found that sufficient inspection activities are in place to prevent the release of nonconforming product related to the reported failure mode.A review of the design history file found that the device is safe and effective for its intended use.A review of the device history record for this complaint lot found no related nonconformances or additional complaints.There is no evidence to suggest there is any nonconforming product in house or out in the field.A review of the product labeling for the device was completed.The product instructions for use (ifu), ¿zenith flex® aaa endovascular graft with the z-trak¿ introduction system¿, provides the following information to the user related to the reported failure mode: 4 warnings and precautions.4.1 general.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 the zenith flex aaa endovascular graft is designed to treat aortic neck diameters no smaller than 18 mm and no larger than 32 mm.The zenith flex aaa endovascular graft is designed to treat proximal aortic necks (distal to the lowest renal artery) of at least 15 mm in length.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.Key anatomical elements that may affect successful exclusion of the aneurysm include severe proximal neck angulation (>60 degrees for infrarenal neck to axis of aaa or >45 degrees for suprarenal neck relative to the immediate infrarenal neck); short proximal aortic neck (<15 mm); an inverted funnel shape (greater than 10% increase in diameter over 15 mm of proximal aortic neck length); and circumferential thrombus and/or calcification at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface.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.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 16 french to 22 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.4.5 implant procedure systemic anti coagulation should be used during the implantation procedure based on hospital and physician preferred protocol.If heparin is contraindicated, an alternative anticoagulant should be considered.Use caution during manipulation of catheters, wires and sheaths within an aneurysm.Significant disturbances may dislodge fragments of thrombus, which can cause distal embolization or rupture of the aneurysm.5 adverse events 5.2 potential adverse events adverse events that may occur and/or require intervention include, but are not limited to: amputation.Arterial or venous thrombosis and/or pseudoaneurysm.Claudication (e.G., buttock, lower limb).Death.Embolization (micro and macro) with transient or permanent ischemia or infarction.Endoprosthesis: occlusion.Graft or native vessel occlusion.Renal complications and subsequent attendant problems (e.G., artery occlusion, contrast toxicity, insufficiency, failure).8 patient counseling information.Device-related risks include occlusion, endoleak, aneurysm enlargement, fracture, potential for reintervention and open surgical conversion, rupture and death.11 directions for use.11.1 bifurcated system.11.1.8 contralateral iliac leg placement and deployment.3.Introduce the contralateral iliac leg delivery system into the artery.Advance slowly until the iliac leg graft overlaps at least one full iliac leg stent (i.E., proximal stent of iliac leg graft) inside the contralateral limb of the main body.If there is any tendency for the main body graft to move during this maneuver, hold it in position by stabilizing the gray positioner on the ipsilateral side.4.Confirm position of distal end of the iliac leg graft.Reposition the iliac leg graft if necessary to ensure both internal iliac patency and a minimum overlap of one full iliac leg stent (i.E., proximal stent of iliac leg graft, maximum overlap of 1.5 stents) within the main body endovascular graft.11.1.11 ipsilateral iliac leg placement and deployment 2.Advance slowly until the ipsilateral iliac leg graft overlaps a minimum of one full iliac leg stent (i.E., proximal stent of iliac leg graft) inside the ipsilateral limb of the main body.3.Confirm position of distal end of the iliac leg graft.Reposition the iliac leg graft if necessary to ensure internal iliac patency.Additionally, the ifu for the leg grafts, [t_zaaasz_rev3] ¿zenith® spiral-z aaa iliac leg with the z-trak¿ introduction system¿, states the following: 4 warnings and precautions.4.2 patient selection, treatment and follow-up.Pre-existing regions of stenosis/narrowing (less than approximately 20 mm id in the aorta or 7 to 8 mm id in the iliacs) have been shown to increase the risk of a thromboembolic event (e.G., graft limb occlusion).The potential for this increased risk in these patients may preclude placement of an endovascular graft.Patients with poor outflow or a hypercoagulable state (e.G., cancer) may be at an increased risk of a thromboembolic event.Based on the information provided, no inspection of the of product, and the results of the investigation, a definitive cause can be traced to use error and patient condition.It was reported the patient had infrainguinal peripheral arterial disease.This condition can narrow the arteries to reduce blood flow to the limbs, which may increase the risk of occlusion as noted in the ifu.No preoperative, intraoperative, or postoperative imaging was provided by the customer, so graft placement could not be ruled out as a potential cause.Additionally, thrombus formation is a known inherent risk of these devices.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 AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9466645
• Report Number: 1820334-2019-03106
• Device Sequence Number: 13989742
• Product Code: MIH
• UDI-Device Identifier: 10827002484020
• UDI-Public: (01)10827002484020(17)200215(10)8572383
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2020

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: 02/15/2020
• Device Model Number: N/A
• Device Catalogue Number: TFFB-22-82-ZT
• Device Lot Number: 8572383
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 04/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 77 YR