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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problems Rupture (2208); No Code Available (3191)

Event Date 07/24/2020

Event Type  Injury  

Manufacturer Narrative

Implant date: 2012.(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 the suprarenal fixation stent of an unknown cook device was compromised (fractured).A patient with "hostile anatomy" had a previous evar procedure completed in 2012 in which this device was implanted and was kept under surveillance afterwards.A follow-up emergency infrarenal endovascular repair procedure was prompted when the patient presented at home with a ruptured aorta on the evening of (b)(6) 2020.Imaging showed that the previously implanted graft's suprarenal fixation stent appeared to be compromised.The original plan was to implant a main body extension cuff, but was later modified to completely relining the implanted graft.During implantation of a main body device on (b)(6) 2020, the physician experienced difficulty inserting the device, which is reported under mfg.Report reference #: 1820334-2020-01437.Afterwards, it was discovered that the device was the wrong size than what was needed.Rather than attempting to unsheathe to gain more delivery system length, the physician decided to withdraw the device and all accessory devices and close the patient.The patient was reported to still be alive.Another emergency evar treatment was performed on (b)(6) 2020.The patient is now reported to be "doing well with good urine output [and] no other concerns." additional information regarding the patient, device, and event has been requested but is currently unavailable.

Manufacturer Narrative

Investigation - evaluation: (b)(6) hospital informed cook on 25jul2020 of an incident involving an unknown zenith alpha main body device.The suprarenal stent reportedly fractured during an evar procedure on (b)(6) 2021.An additional evar procedure was conducted to resolve this as a result.No additional harm was reported.A review of the drawing, instructions for use (ifu), and quality control, as well as a visual inspection of the device, was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, post-operative imaging was provided to cook and sent for expert image review.The expert image review was unable to confirm the alleged failure as it is not represented in the imaging.However, it is stated that severe tortuosity of the infrarenal aorto-iliac segment likely caused or contributed to the reported difficulty.It is also noted that the 95 degree angulation at the infrarenal neck is outside of the patient selection criteria listed in the product ifu.The image reviewer stated that the angulation could have occurred due to disease progression if the tortuosity was not present during the initial repair.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 device history record (dhr) was unable to be completed due to a lack of lot information from the user facility.It should be noted that these devices are distributed via one-device lots.Evidence provided by the complaint facility, a review of the provided imaging, 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.Cook also reviewed product labeling.The product ifu, [t_zaaaf_rev5] ¿zenith flex aaa endovascular graft with the z-trak introduction system,¿ provides the following information to the user related to the reported failure mode: "2 indication for use: the zenith flex aaa endovascular graft with the z-trak introduction system is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair, including adequate iliac/femoral access compatible with the required introduction systems 4.2 patient selection, treatment and follow-up: 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 that 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.4.5 implant procedure: - do not bend or kink the delivery system.Doing so may cause damage to the delivery system and the zenith flex aaa endovascular graft.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 - endoprosthesis: improper placement; incomplete deployment; migration; component separation; suture break; occlusion; infection; stent fracture; graft material wear; dilation; erosion; puncture; perigraft flow; barb separation and corrosion - renal complications and subsequent attendant problems (e.G., artery occlusion, contrast toxicity, insufficiency, failure) - surgical conversion to open repair - vascular spasm or vascular trauma (e.G., iliofemoral vessel dissection, bleeding, rupture, death)" 9 how supplied - inspect the device and packaging to verify that no damage has occurred as a result of shipping.Do not use this device if damage has occurred or if the sterilization barrier has been damaged or broken.If damage has occurred, do not use the product and return to cook." based on the information provided, no product returned, and the results of our investigation, potential root causes have been traced to unintended user error and the patient's condition.It is possible that the patient's severe tortuosity of the infrarenal aorto-iliac segment or 95 degree angulation at the infrarenal neck (outside of ifu recommendations) contributed to this event.It is possible that the angulation could have occurred due to the progression of the disease if the tortuosity was not present during the initial repair.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.

• Brand Name: UNKNOWN
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10370581
• MDR Text Key: 203501358
• Report Number: 1820334-2020-01440
• 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
• Report Date: 02/04/2021

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
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/25/2020
• Initial Date FDA Received: 08/05/2020
• Supplement Dates Manufacturer Received: 02/02/2021
• Supplement Dates FDA Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR