MAUDE Adverse Event Report: COOK INC; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Device Problems Fluid/Blood Leak (1250); Migration (4003)

Patient Problems No Information (3190); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Medical device - rpn: device rpn is one of the following: tffb-30-96; tffb-30-96-zt; tfle-16-56-zt; zsle-16-56-zt; tfle-20-56-zt; zsle-20-56-zt.(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported that an unknown cook graft migrated following implantation, resulting in "extension aneurysmal disease" and an endoleak (type currently unknown).Consequently, the device was explanted.Between the implant and explant procedure the patient also underwent open bypass surgery.It was also noted that the patient was taking plavix.The patient's aneurysm prior to implantation was described as "uncomplicated" and the patient had one ct per year to monitor disease progression.Additional information regarding the patient, device, and event has been requested but is currently unavailable.The patient's status is reportedly good following the explant procedure.

Manufacturer Narrative

B3: date of event: this event occurred at the "end of on (b)(6) 2020", nine years after initial implantation.D4: rpn: the devices implanted into the patient were reported to be: tffb 30 96, tfle 16 56 (right), tfle 20 56 (left).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 Description

Additional information regarding patient / event details was received on 11aug2020 and 13aug2020.The intensive care patient had no evolution of the proximal aneurysm neck.The patient was compliant with follow-up protocol.The migration was noted on the last ct on (b)(6) 2020.The patient's disease progression resulted in dilation of the proximal and distal aneurysm neck.The patient was reported to be doing "good" after open bypass on aorta surgery.Between implant and explant of the grafts, the patient underwent "open surgery, bypass open".Causes of the explantation were reported to be device migration, type 1 endoleak, and aneurysmal disease extension.

Manufacturer Narrative

Investigation - evaluation: clinique geoffroy informed cook on 30jul2020 of an incident involving an unknown zenith flex aaa endovascular graft bifurcated main body.The device reportedly migrated after implantation on 11jul2011.An endoleak was noted as a result.Communication with the user facility clarified that dilation of the proximal neck was noted.An open procedure was successfully performed to remove the device and no additional harm was reported.A review of the drawing, instructions for use (ifu), and quality control of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.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 design history file (dhf) showed that this device is both safe and effective for its intended use.A review of the device history record (dhr) was unable to be completed due to a lack of lot information from the user facility.Given this information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The product ifu, [t_zaaaf_rev5] ¿zenith flex aaa endovascular graft with the z-track introduction system,¿ provides the following information to the user related to the reported failure mode: "2 indications for use the zenith flex aaa endovascular graft with the h&l-b one-shot introduction system is indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms having morphology suitable for endovascular repair, including: adequate iliac/femoral access compatible with the required introduction systems, non-aneurysmal infrarenal aortic segment (neck) proximal to the aneurysm: with a length of at least 15 mm, with a diameter measured outer wall to outer wall of no greater than 32 mm and no less than18 mm.With an angle less than 60 degrees relative to the long axis of the aneurysm, and with an angle less than 45 degrees relative to the axis of the suprarenal aorta.Iliac artery distal fixation site of greater than 10 mm in length and 7.5-20 mm in diameter (measured outer wall to outer wall).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 [.] 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 at the proximal aortic neck and distal iliac artery interface [¿] necks exhibiting these key anatomical elements may be more conducive to graft migration or endoleak." lengths the long-term performance of endovascular grafts has not yet been established.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 aneurysm or changes in the structure or position of the endovascular graft) should receive enhanced follow-up.5 adverse events: 5.2 potential adverse events: adverse events that may occur and/or require interventions include, but are not limited to : aneurysm enlargement, aneurysm rupture and death, endoleak, 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 surgical conversion to open repair.12 imaging guidelines and postoperative follow-up: 12.1 general: the long-term performance of endovascular grafts has not yet been established.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 aneurysm or changes in the structure or position of the endovascular graft) should receive enhanced follow-up.Physicians should evaluate patients on an individual bases 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.This schedule continues to be the minimum requirement for patient follow-up and should be maintained in the absence of clinical symptoms (e.G., pain, numbness, weakness).Patient 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.Annual imaging follow-up should include abdominal radiographs and both contrast and non-contrast ct examinations.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.The abdominal radiographs provide information on device integrity (separation between components, stent fracture and barb separation).¿ based on the information provided, no product returned, and the results of our investigation, the likely root cause for this event can be traced to the patient's condition including their anatomy and physiology due to disease progression.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering 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.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10402388
• MDR Text Key: 202769413
• Report Number: 1820334-2020-01487
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2021

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/30/2020
• Initial Date FDA Received: 08/13/2020
• Supplement Dates Manufacturer Received: 08/11/2020; 02/16/2021
• Supplement Dates FDA Received: 08/28/2020; 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR