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

Model Number	G48433
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	01/12/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
(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 on (b)(6) 2018, a (b)(6) year old male patient with an abdominal aortic aneurysm (aaa) underwent a procedure to have a zenith flex aaa endovascular graft bifurcated main body implanted.The implant could not be done, so the patient was converted to conventional surgery.Furthermore, it was reported the patient died.However, the date and cause of death were not provided.On july 2, 2018, additional event details were provided that a junior partner decided to do the case alone.The case was performed without a cook or distributor¿s representative or even the senior partner (and most experienced user/physician) present.The junior partner initially alleged that the device had a malfunction.A meeting was held between the distributor and the senior partner of the practice group and most experienced user of the device.The senior partner confirmed the zenith graft was deployed incorrectly inside of the patient as a result of user error.No further details were provided.Additional event details, further details of the death, an autopsy report or death certificate, imaging, and the delivery system have been requested but not received at this time.
Additional Manufacturer Narrative
Investigation ¿ evaluation.Requests for additional event details, patient anatomy, planning and sizing sheet, imaging of the event and autopsy report were sent to the distributor and customer; however, no additional information was provided.The device was not returned for an evaluation and no photographs were provided.Without the complaint device, a physical investigation was not able to be completed.A document based investigation was performed.A review of the device history record, design history files, instructions for use, manufacturing instructions and quality control data was conducted.The device history record was reviewed, for lot 8146789 (finished assembly) and sa6929801 (graft).As noted on sa6929801, the outer bag was damaged by qc.However, this was reworked.Design verification and validation activities performed have shown that the device meets design input requirements and user needs.Biocompatibility testing of the grafts has been completed.The instructions for use (ifu) lists a contraindication for patients with known sensitivities or allergies to stainless steel, polyester, polypropylene, urethane, ptfe, nylon or gold.This device undergoes a validated sterilization process.It was confirmed that the complaint device was deployed inside the patient.However, it is unknown what part of the procedure was done incorrectly.Per the additional information provided, it is evident that the cause for the patient death is due to incorrect device placement, leading to surgery.Quality control specifications for device labeling, inspection of main body graft and delivery system, manufacturing instructions for the mainbody device, and design history files were reviewed and no evidence was found that the device is manufactured out of specification.Each zenith device is provided with instructions for use (ifu), which list the patient's anatomical requirements, warnings, precaution and correct deployment procedure.Based on the information provided by the customer, the cause for patient death in this case is product use or handling related: user technique.A quality engineer risk assessment was conducted to assess the risk of this failure mode and concluded a change is not required, thus no risk reduction activities are required at this time.There was no issue with the device, however, since the device was used incorrectly, this would have increased in disease progression requiring surgery and resulting in patient death.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.
Event or Problem Description
No additional information has been reported since the submission of the initial report on 7/11/2018.

• 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: 7680495
• Report Number: 1820334-2018-01977
• Device Sequence Number: 848929
• Product Code: MIH
• UDI-Device Identifier: 10827002484334
• UDI-Public: (01)10827002484334(17)190828(10)8146789
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2019
• Device Model Number: G48433
• Device Catalogue Number: TFFB-36-113-ZT
• Device Lot Number: 8146789
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/12/2018
• Supplement Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 08/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR