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	03/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: clinical specialist.Concomitant medical products: sizing pigtail catheter, 2 60 cm lunderquist wires, kmp catheter, 32 coda balloon, 6 fr, 55 curved ansel sheath, 1 260cm rosen wire, 7 x 22 icast stent, fenestrated proximal and distal main body, zsle 16-74, zsle-16-56, 20 fr sheath, 3 per close closure devices, vanschie 4 catheter.(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 zenith flex with spiral-z technology aaa endovascular graft iliac leg had a "blush of contrast outside the graft below the overlap of the body and limb." during the placement of a zenith flex with spiral-z technology aaa endovascular graft iliac leg, there was no flow down the right iliac.The contrast run was performed again while pulling back the syringe in the right groin.There appeared to be flow, as well as a blush of contrast outside the graft below the overlap of the body and the limb.The flush catheter was pulled into the limb.The contrast study was repeated and contrast remained outside of the limb.The zenith flex with spiral-z technology aaa endovascular graft iliac leg was then relined.Contrast blush was no longer present after original device was relined.Heparin was administered to the patient during the procedure.The patient's vessel anatomy was not torturous, however, the patient had a little bit of calcium present at the bifurcation.The shape of the neck anatomy was noted to be fairly parallel.The graft was ballooned at the overlap of the graft and seal zones, although the exact inflation volume is unknown.There was no graft obstruction of high blood pressure within the graft during the endoleak.A cook medical representative was present during the case and reported that, "i supported a case yesterday where the graft appeared to have a tear or break in the graft after implantation.It did not cause any adverse events to the patient although it did require a second limb to be placed to reline the initial graft placed".The patient was doing well after the operation.Planning and sizing information as well as pre and post operative images have been requested but are not available at the time of this report.
Additional Manufacturer Narrative
B5: it was determined that the event is not reportable under fda 21cfr part 803, as the endoleak was corrected by the placement of an extension device per device labeling.No additional reports will be sent regarding his event.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, that a death or serious injury occurred, nor that any cook device caused, 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
• MDR Report Key: 8488604
• Report Number: 1820334-2019-00765
• Device Sequence Number: 19324286
• Product Code: MIH
• UDI-Device Identifier: 10827002552439
• UDI-Public: (01)10827002552439(17)220205(10)9467128
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2019

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: 02/05/2022
• Device Model Number: N/A
• Device Catalogue Number: ZSLE-20-90-ZT
• Device Lot Number: 9467128
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/21/2019
• Supplement Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 08/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR