MAUDE Adverse Event Report: COOK INC ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	10/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: phone: (b)(6).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 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 or that a death or serious injury occurred; nor is it admission 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
It was reported to cook that a provider suspected a type 3b endoleak at the conclusion of a procedure where a cook zenith flex with spiral-z technology aaa endovascular graft iliac leg was placed.The patient had been diagnosed with an aortic aneurysm and atrial fibrillation (recent diagnosis, date unknown).On (b)(6) 2023 he underwent a fenestrated endovascular aortic repair (fevar) where the following cook devices were implanted: cook custom made fenestrated graft, (rpn: aaa-reinforced-fen-prox, lot number ac1125954).Cook custom made bifurcated main body graft (rpn: aaa-bifurcated-graft, lot number ac1125955).Cook zenith flex with spiral-z technology aaa endovascular graft iliac leg (rpn: zsle-20-56-zt, lot number 14220387).Cook zenith flex with spiral-z technology aaa endovascular graft iliac leg (rpn: zsle-20-56-zt, lot number 14154411).All grafts were implanted with technical success.However, on the final run, there was an endoleak noted.The source of the endoleak was unclear and could not be determine or classified by any party on the day of the procedure.Multiple angiography runs were completed at the proximal end around the visceral vessels and also in each limb.No further confirmation of where the leak was originating from could be determined on the day of the procedure.A competitor's short cuff was placed distal to the lowest renal artery but distal enough to allow room for further intervention in the future.The cuff was placed in an effort to exclude an endoleak from the junction of the proximal and distal custom-made grafts.However, the endoleak persisted on the completion angiography.The facility placed an order for a custom made short distal bifurcated body graft with an inverted limb section in order to reline the graft and exclude the endoleak.Further endovascular aortic repair (evar) was completed on (b)(6) 2023.The patient's in-situ grafts were re-lined using the following cook grafts: cook custom made graft (rpn: aaa-body-inverted-leg, lot number ac1141169) cook zenith flex with spiral-z technology aaa endovascular graft iliac leg (rpn: zsle-16-56-zt, lot number14993093).Additional cook devices that were reported to be customary to support the procedure included: cook lunderquist wire, cook ansel sheaths, and cook coda balloons.The endoleak resolved on the completion angiogram.The relining procedure was considered a technical success deemed by the physician team.The focus of this report is the type 3b endoleak on the cook zenith flex with spiral-z technology aaa endovascular graft iliac leg (rpn: zsle-20-56-zt, lot number 14154411) that required relining.An additional report will be submitted 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
Correction: this report is being sent to indicate the complaint event is not reportable.Upon review of provided information, cook was unable to confirm this complaint.The expert image review only identified one type 3b endoleak which is captured in report # (b)(4).Therefore, this event is not considered reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury, or reportable product malfunction.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.

• Brand Name: ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
• 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: 17945034
• Report Number: 1820334-2023-01392
• Device Sequence Number: 12673854
• Product Code: MIH
• UDI-Device Identifier: 10827002552415
• UDI-Public: (01)10827002552415(17)240819(10)14154411
• Combination Product (Y/N): N
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2024

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: 08/19/2024
• Device Model Number: N/A
• Device Catalogue Number: ZSLE-20-56-ZT
• Device Lot Number: 14154411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 01/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2021
• 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: COOK RPN: AAA-BIFURCATED-GRAFT, LOT: AC1125955; COOK RPN: AAA-REINFORCED-FEN-PROX, LOT: AC1125954; COOK RPN: ZSLE-20-56-ZT, LOT: 14220387
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male