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	G55231
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 there was thrombus development in a zenith flex with spiral-z technology aaa endovascular graft iliac leg.The graft was implanted in a (b)(6) year old male patient on (b)(6) 2017, along with 2 other zenith legs, and 1 zenith main body.At the time of implantation, it was noted the patient had a tight aortic bifurcation measuring 18x16mm, and "kissing" balloons were used to ensure good flow down both limbs at the end of the procedure.Initial follow up scans showed no thrombus, but follow up scans performed later demonstrated an increasing level of thrombus within the ipsilateral (right) limb.It is unknown at this time which, or how many of the patient's devices showed signs of thrombus.Therefore, reports have been created for all devices implanted in this patient and are reported under mdrs with patient identifier (b)(6).After the first notice of thrombus, the patient began antiplatelet therapy, and after his most recent scant, he started on oral anticoagulants.It was reported the patient will require an additional procedure to ensure blood flow through the limb, but no procedure or plan for a procedure has yet been reported.
Additional Manufacturer Narrative
Correction: upon completion of the investigation, this complaint was unable to be confirmed.Given the available information and imaging, it was determined that thrombus did not form in this device.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 information regarding the patient and/or event has 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: 10567447
• Report Number: 1820334-2020-01725
• Device Sequence Number: 14137700
• Product Code: MIH
• UDI-Device Identifier: 10827002552316
• UDI-Public: (01)10827002552316(17)190510(10)6884041
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/10/2019
• Device Model Number: G55231
• Device Catalogue Number: ZSLE-13-56-ZT
• Device Lot Number: 6884041
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 09/22/2020
• Supplement Report FDA Received Date: 12/14/2020
• 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: TFFB-30-111-ZT, LOT 6494353; ZSLE-13-90-ZT, LOT 7284891; ZSLE-16-90-ZT, LOT 7290511; TFFB-30-111-ZT, LOT 6494353; ZSLE-13-90-ZT, LOT 7284891; ZSLE-16-90-ZT, LOT 7290511
• Patient Age: 74 YR