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	No Code Available (3191)
Date of Event	11/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Differing information for second device: product identifier: g55241-zsle-20-56-zt, product lot # (mdr): 9426425, rpn: zsle-20-56-zt, expiration date: 01/24/2022, product lot #: 9426425, udi: (b)(4), manufacture date: 01/24/2019.(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 a patient developed a type 3 endoleak following implantation of two zenith flex with spiral-z technology aaa endovascular graft iliac legs.Four cook grafts including a fenestrated main body graft were implanted on (b)(6) 2020.Approximately two months after initial implantation, during a follow-up visit, a ct scan revealed an endoleak from an unknown location which was believed to be a type 3.The patient was scheduled for a "limb extension or cuff procedure" as the physician was initially unsure which secondary procedural approach was appropriate.Several angiographies were completed and the right limb was relined from top to bottom.Additionally, two competitor leg grafts were implanted, one on each side as the exact location of the leaking was undetermined.A cook balloon was used on both sides and a final angiography was completed, showing no endoleaks present.A 30cc syringe was used throughout the procedure.No other adverse effects to the patient have been reported.The patient outcome has been described as "as expected, good and fixed".Other events regarding the patient's secondary procedure are also reported under patient identifier (b)(6).
Additional Manufacturer Narrative
Correction: upon completion of the investigation, this complaint was unable to be confirmed.Given the available information and expert image review derived from supplied imaging, it was determined that an endoleak did not form on this device/these devices.No further reports will be submitted regarding this event as it no longer meets the reporting criteria.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
No additional patient/event details have been received since the previous medwatch report was sent.

• 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
• MDR Report Key: 10896986
• Report Number: 1820334-2020-02176
• Device Sequence Number: 11576849
• Product Code: MIH
• UDI-Device Identifier: 10827002552422
• UDI-Public: (01)10827002552422(17)230401(10)13086717
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2023
• Device Model Number: N/A
• Device Catalogue Number: ZSLE-20-74-ZT
• Device Lot Number: 13086717
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/15/2020
• Supplement Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 03/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 30CC SYRINGE; ZFEN-D-12-28-91-C; ZFEN-P-2-28-124-R
• Outcome Attributed to Adverse Event: Required Intervention