MAUDE Adverse Event Report: COOK INC ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G48408
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer (person): phone: (b)(6), line 2: (b)(6), postal code: (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 reported that blood clots were found in a zenith flex aaa endovascular graft bifurcated main body during a secondary procedure to treat thrombus in a zenith leg, reported in mdr# 1820334-2020-01550.
Additional Manufacturer Narrative
Investigation ¿ evaluation.It was reported that blood clots were found in a zenith flex aaa endovascular graft bifurcated main body during a secondary procedure to treat thrombus in a zenith leg, reported previously in mdr#1820334-2020-01550.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 complaint device was not returned; however, imaging was provided and sent for expert review.The complaint of occlusion of the right iliac leg graft is evaluated in mdr#1820334-2020-01550.The image reviewer also confirmed mural thrombus in the main body graft (tffb-24-96-zt, covered in this report) as a likely extension of the zsle thrombus.Image review also notes that both zsle grafts are inserted 4.5 mm superior to the flow divider.The dead space created by this was filled with thrombus.Additionally, a document based investigation evaluation was performed.A review of the device master record (dmr) found that proper procedures are in place to identify and prevent this failure mode prior to device distribution.A review of the design history file (dhf) found that the affected product is safe and effective for its intended use.A review of the device history record (dhr) and a database search found no nonconformances or additional complaints associated with this device lot (6509336).It should be noted that the tffb-24-96-zt is a one-device lot.This investigation concludes that the complaint device was manufactured to specification.Because there are adequate inspection activities in place, objective evidence that the dhr was fully executed, no related non-conformances, and no other lot-related complaints received from the field, this investigation has also concluded that there is no evidence that non-conforming product exists in house or in the field.A review of the product labeling for the device was completed.The instructions for use state the following instructions 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: 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: arterial or venous thrombosis and/or pseudoaneurysm.Claudication (e.G., buttock, lower limb).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: physicians must advise each patient that it is important to seek prompt medical attention if they experience signs of limb occlusion, aneurysm enlargement or rupture.Signs of graft limb occlusion include pain in the hip(s) or leg(s) during walking or at rest or discoloration or coolness of the leg.Aneurysm rupture may be asymptomatic, but usually presents as: pain; numbness; weakness in the legs; any back, chest, abdominal or groin pain; dizziness; fainting; rapid heartbeat or sudden weakness.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.Based on the information provided, inspection of the provided imaging, and the results of the investigation, a definitive cause for this event was traced to patient condition, as the patient's history of smoking and condition of severe hypertriglyceridemia are the most likely contributing factors to thrombus formation.Additionally, thrombus formation is a known inherent risk of using this 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.
Event or Problem Description
No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

• 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: 10780435
• Report Number: 1820334-2020-02001
• Device Sequence Number: 1138092
• Product Code: MIH
• UDI-Device Identifier: 10827002484082
• UDI-Public: (01)10827002484082(17)180118(10)6509336
• Combination Product (Y/N): N
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2021

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: 01/18/2018
• Device Model Number: G48408
• Device Catalogue Number: TFFB-24-96-ZT
• Device Lot Number: 6509336
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 02/22/2021
• 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: GORE VIAHAHN VBX - BXA077901J; GORE VIAHAHN VBX - BXA115901J; GORE VIAHAHN VBX - BXA117901J
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR