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

Model Number	G48413
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	07/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 zenith flex aaa endovascular graft bifurcated main body stenosed.During a routine follow-up appointment, the patient presented with possible stenosis "inside the overlap of the ipsilateral limb and the proximal edge of the iliac leg graft".As a result, balloon angioplasty was successfully performed to open the potentially stenosed segment.It was also reported that the patient will be seen by the physician approximately one month after the intervention took place.No other adverse effects to the patient have been reported.An additional event regarding this patient is also reported under patient identifier: (b)(6).
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
Investigation - evaluation: on 09jul2021, cook became aware of an event in which an 82-year-old male patient with an iodine allergy presented with possible stenosis in the main body overlap during a routine follow-up.The complaint device, a zenith flex aaa endovascular graft main body (rpn: tffb-26-96-zt, lot: 4632107), was implanted on (b)(6) 2014 along with two iliac leg grafts.Stenosis was contained inside the overlap of the ipsilateral limb and the proximal edge of the iliac leg graft.A balloon angioplasty to open the left common iliac leg graft segment was performed.The issue seemed to be resolved and the physician was happy with the outcome.A review of documentation including the complaint history, device history record (dhr), drawing, instructions for use (ifu), quality control, and specifications of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, intraoperative imaging was provided to cook and submitted for review.The review noted that based on what was provided, it cannot be determined if stenosis is present post-implantation.Cook has concluded that the device was manufactured to specification.Additionally, 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 design history file (dhf) showed that this device is both safe and effective for its intended use.A review of the dhrs for the reported complaint device lot (4632107) and the related graft/graft kit subassembly lots revealed no recorded nonconformances relevant to the reported failure mode.It should be noted that tffb- devices are distributed via one-device lots, giving no indication of nonconforming product in house.A database search did not identify any other events associated with the reported device lot.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The device was packaged with ifu t_zaaaf_rev4, which provides the following in relation to the reported failure mode: "warnings and precautions: patient selection, treatment and follow-up key anatomical elements that may affect successful exclusion of the aneurysm include sever 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 (measure 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 sheaths.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.Inability to maintain patency of at least one internal iliac artery or occlusion of an indispensable inferior mesenteric artery may increase the risk of pelvic/bowel ischemia.Adverse events: potential adverse events: claudication (e.G., buttock, lower limb); endoprosthesis: improper component placement; incomplete component deployment; component migration; suture break; occlusion; infection; stent fracture; graft material wear; dilatation; erosion; puncture; perigraft flow; barb separation and corrosion.Graft or native vessel occlusion.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.Physicians should refer patients to the patient guide regarding risks occurring during or after implantation of the device.Procedure-related risks include cardiac, pulmonary, neurologic, bowel and bleeding complications.Device-related risks include occlusion, endoleak, aneurysm enlargement, fracture, potential for reintervention and open surgical conversion, rupture and death (see section 5.1, observed adverse events and section 5.2 potential adverse events).The physician should complete the patient i.D.Card and give it to the patient so that he/she can carry it with him/her at all times.The patient should refer to the card anytime he/she visits additional health practitioners, particularly for any additional diagnostic procedures (e.G., mri).Imaging guidelines and postoperative follow-up: general.Physicians should evaluate patients on an individual basis and prescribe their follow-up relative to the needs and circumstances of each individual patient.The recommended imaging schedule is presented in table 12.1.1.This schedule was used in the pivotal trial and is recommended even in the absence of clinical symptoms (e.G., pain, numbness, weakness).Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysms or changes in the structure or position of the stent graft) should receive follow-up at more frequent intervals.The combination of contrast and non-contrast ct imaging provides information on aneurysm diameter change, endoleak, patency, tortuosity, progressive disease, fixation length and other morphological changes.Duplex ultrasound imaging may provide information on aneurysm diameter change, endoleak, patency, tortuosity, and progressive disease.In this circumstance, a non-contrast ct should be performed to use in conjunction with the ultrasound.Ultrasound may be a less reliable and sensitive diagnostic method compared to ct." based on the information provided, no product returned, and the results of the investigation, a potential root cause for this event has been traced to the patient's condition.It should be noted that stenosis is a known inherent risk of using this device.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.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
• 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: 12167083
• Report Number: 1820334-2021-01794
• Device Sequence Number: 6753833
• Product Code: MIH
• UDI-Device Identifier: 10827002484136
• UDI-Public: (01)10827002484136(17)151101(10)4632107
• 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: 2014
• 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
• Report Date (Section B): 11/15/2021

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: 11/01/2015
• Device Model Number: G48413
• Device Catalogue Number: TFFB-26-96-ZT
• Device Lot Number: 4632107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2021
• Supplement Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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: COOK ZSLE-13-107-ZT, LOT 3990720; COOK ZSLE-20-56-ZT, LOT 4240127
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 82 KG