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
(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 an endoleak persisted following implantation of a zenith flex with spiral-z technology aaa endovascular graft iliac leg during a relining procedure.A type 3 endoleak was discovered via ct imaging during a follow-up.The exact location of the endoleak was unable to be determined.Consequently, a follow-up procedure was scheduled.The patient was brought in for "limb extension or cuff procedure" as the physician was initially unsure which procedural approach was appropriate.Several angiographies were completed and the right limb was relined from top to bottom.Following ballooning and another angiography, leaking was still occurring.Two competitor balloons were then used in an attempt to expand and another angiography was performed, which showed that though the situation had improved, there was still leaking present from an undetermined location.As a result, 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.Ballooning was completed in the middle of the grafts and down through both limbs.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 initial procedure are also reported under patient identifier (b)(6).
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.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: 10896171
• Report Number: 1820334-2020-02175
• Device Sequence Number: 16957589
• Product Code: MIH
• UDI-Device Identifier: 10827002552439
• UDI-Public: (01)10827002552439(17)230422(10)13138420
• 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
• 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: 04/22/2023
• Device Model Number: N/A
• Device Catalogue Number: ZSLE-20-90-ZT
• Device Lot Number: 13138420
• 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: 14X4 ATLAS BALLOONS, QTY. 2; 30CC SYRINGE; GORE 20X16X100 LIMBS, QTY. 2
• Outcome Attributed to Adverse Event: Required Intervention