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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter occupation: district manager.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 plaque narrowed the right renal following implantation of a zenith flex aaa endovascular graft bifurcated main body.When the graft was deployed, it looked like plaque from the patient's aorta may have popped off and narrowed the right renal artery.A wire and multiple catheters were attempted to pass, eventually a steerable sheath from another manufacturer was used to get a wire out the right renal artery.The stent and renal were ballooned and a 6x22 stent was placed.Angiography was done and the renal "looked good." there was no regimen of anticoagulant or antiplatelet medication prescribed before the initial evar procedure.The patient was prescribed plavix following placement of the grafts, however the dose and duration are unknown.Calcifications were noted in the common iliacs, as well as a proximal spot in the right renal artery.The aortic neck was 2cm.The renal occlusion was noted on the final angiography run.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation.The cook sales representative for the guthrie clinic, sayre, pennsylvania reported that plaque was dislodged during a procedure and narrowed the right renal artery.The complaint device was a zenith flex aaa endovascular graft bifurcated main body (tffb-28-82-zt).The patient was a 79-year-old male who weighed 80 kilograms.He had calcifications present in the common iliac arteries and proximal to the right renal artery.His aortic neck measured 20 mm in diameter.The patient underwent endovascular aortic repair (evar) on (b)(6) 2021.When the zenith flex aaa endovascular graft bifurcated main body (tffb-28-82-zt) was deployed, it looked like a plaque from the patient¿s aorta ¿popped off¿ and narrowed the right renal artery.This was identified in the final angiography run for the procedure.Unsuccessful attempts were made to pass a wire and multiple catheters to resolve the occlusion.Finally, a steerable sheath (oscor) was used, and a wire was able to be inserted into the right renal artery.Ballooning was completed across the stent and renal artery with an angioplasty balloon (boston scientific mustang balloon, 5x2).A competitor¿s stent (icast) in the right renal artery.Another angiography scan was completed, and the renal artery was reported to ¿look good.¿ reviews of the documentation including the complaint history, device history record, drawing, instructions for use (ifu) and quality control procedures of the device, were conducted during the investigation.The complaint device was not returned for evaluation; therefore, no physical examination could be conducted.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 device history record (dhr) for lot 13976903 found no nonconformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with this lot number.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: 9 how supplied - the product is sterile if the package is unopened or undamaged.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.Evidence provided by the complaint facility, device history record, complaint history, and manufacturing documents, suggest that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.Based on the information provided, no returned product and the results of our investigation, it was concluded that the cause cannot be traced to the device and is likely an adverse event related to calcification of the patient¿s vessels.The appropriate personnel have been notified.Per the risk assessment no further action is required.We 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
• 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: 13011362
• Report Number: 1820334-2021-02682
• Device Sequence Number: 11216806
• Product Code: MIH
• UDI-Device Identifier: 10827002484174
• UDI-Public: (01)10827002484174(17)230526(10)13976903
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2022

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: 05/26/2023
• Device Model Number: N/A
• Device Catalogue Number: TFFB-28-82-ZT
• Device Lot Number: 13976903
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2021
• Supplement Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2021
• 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: 5X2 MUSTANG BALLOON; 6X22 ICAST STENT; OSCOR SHEATH; ZSLE-16-56-ZT; ZSLE-16-74-ZT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 80 KG