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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer (person): mobile: (b)(6).Initial reporter postal code: (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.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 or Problem Description
A patient underwent endovascular aortic repair (evar) for an abdominal aortic aneurysm on (b)(6) 2013.During the procedure the following devices were implanted: zenith flex aaa endovascular graft bifurcated main body (rpn: tffb-28-96-zt, lot number: 3288483); zenith flex with spiral-z technology aaa endovascular graft iliac leg (rpn: zsle-16-74-zt, lot number: 3626614) placed in the right common iliac artery; and zenith flex with spiral-z technology aaa endovascular graft iliac leg (rpn: zsle-20-90-zt, lot number: 2868888) placed in the left common iliac artery.A routine follow-up scan (date unknown) showed a type 1a endoleak on the zenith flex aaa endovascular graft bifurcated main body and a type 1b endoleak on the zenith flex with spiral-z technology aaa endovascular graft iliac leg (rpn: zsle-20-90-zt, lot number: 2868888).Additional information was provided on 19jan2023 indicating that a fenestrated graft repair for the type 1a endoleak, as well as standard zisl limb extensions, that will be used to repair both type 1b endoleaks.The focus of this report is the type 1b endoleak on the zenith flex with spiral-z technology aaa endovascular graft iliac leg (rpn: zsle-16-74-zt, lot number: 3626614) that was placed in the right common iliac artery.Related reports for the same patient have been submitted under mdr #1820334-2023-00002 and mdr #1820334-2023-00001.
Event or Problem Description
In additional information received on 12feb2023, the area rep confirmed that there was no type 1b endoleak on the right iliac leg graft.
Additional Manufacturer Narrative
Correction: in additional information received on 12feb2023, the area representative confirmed that only one type 1b endoleak on the left iliac leg (manufacturer reference #: 1820334-2023-00002) occurred during this case.There was no type 1b endoleak on the right iliac leg.This event is no longer considered reportable under fda 21 cfr part 803, as it does not meet the criteria for a serious injury and/or product malfunction.No additional reports will be submitted for this event.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: 16357515
• Report Number: 1820334-2023-00123
• Device Sequence Number: 20400919
• Product Code: MIH
• UDI-Device Identifier: 10827002552385
• UDI-Public: (01)10827002552385(17)150801(10)3626614
• Combination Product (Y/N): N
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2023

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: 08/01/2015
• Device Model Number: N/A
• Device Catalogue Number: ZSLE-16-74-ZT
• Device Lot Number: 3626614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 02/12/2023
• Initial Report FDA Received Date: 02/10/2023
• Supplement Report FDA Received Date: 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2012
• 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, TFFB-28-96-ZT, LOT 3288483; COOK, ZSLE-20-90-ZT, LOT 2868888
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male