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	G55239
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant products: lunderquist wire, uniglide wire, pig tail catheter, coda balloon.(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 initially reported the patient had abdominal aortic aneurysm (aaa) repair of a 13cm aaa on (b)(6) 2014 using tffb main body and five leg extensions.Looking at the 2018 computerized tomographic angiography (cta), it appears there is a 13mm zsle sealing into the flex body on each side used as bridging limbs.Sealing into the 13mm leg on the right appears to be the zsle-16, and the two zsle-24's are both on the left side with one telescoping out the other.It was reported the following devices were implanted during the procedure performed on (b)(6) 2014: tffb-24-125-zt, zenith flex aaa endovascular graft bifurcated main body, lot # 4451230; zsle-24-90-zt, zenith flex with spiral-z technology aaa endovascular graft iliac leg, lot # 4586197; zsle-13-74-zt, zenith flex with spiral-z technology aaa endovascular graft iliac leg, lot # 4618971; zsle-13-90-zt, zenith flex with spiral-z technology aaa endovascular graft iliac leg, lot # 4424118; zsle-24-74-zt, zenith flex with spiral-z technology aaa endovascular graft iliac leg, lot # 4304237; zsle-16-90-zt, zenith flex with spiral-z technology aaa endovascular graft iliac leg, lot # 4375912.2015 follow up was fine.It is not clear whether there was subsequent follow up but the 2018 radiology report and cta show occluded left side.The doctor plans to attempt to re-establish flow down this side.Additional information received (b)(4) 2018.It was reported after re-establishing flow down the left side on (b)(6) 2018, the dr.Had been running a ¿lysis infusion¿ for two days.He then brought the patient back to theatre today, (b)(6) 2018, to re-intervene.He felt the left side whilst open showed signs of opacification compared to the right.He was also concerned that the top of the zsle-16-90-zt on the right side (near the main body tick marker) was impinged.He improved both concerns by placing two ¿kissing¿ 10mm x 57mm begraft covered balloon expandable stents from the proximal edge of each leg extension (the zsle-13¿s that extend above the flow divider).He felt this opened up the top of the zsle-16-90-zt nicely and improved flow down the left.To further improve the left side flow, he then extended beyond the distal edge of the first begraft with another 10mm x 37mm.He supplied two images.The ¿pre stent¿ shows the constrained stent on the right, and opacification on the left.The ¿post stent¿ pic shows the much-improved result for both concerns.The patient also revealed they had not been taking any anticoagulation medication, including stopping aspirin.Dr.Was concerned to hear this and has prescribed a regimen including plavix.The following separate complaints and medwatch reports were created to capture the three issues identified.Occlusion on left side involving the zsle-24-90-zt, lot # 4586197 - mfr.Report # 1820334-2018-03267.Occlusion on left side involving the zsle-24-74-zt, lot # 4304237 - mfr.Report # 1820334-2018-03268.Top of the zsle-16-90-zt, lot # 4375912 right side impinged - mfr.Report # 1820334-2018-03269.
Additional Manufacturer Narrative
Investigation/evaluation: the device was not available for evaluation as it remains implanted in the patient.Imaging was provided for review.A document based investigation has been performed including a review of the provided imaging, device history record, instructions for use, manufacturing instructions, quality control data, and specifications.The physician supplied two images.The ¿pre-stent¿ shows the constrained stent on the right, and opacification on the left.The ¿post stent¿ picture shows the much-improved result for both concerns.A computerized tomographic angiography (cta) performed prior to the reported secondary intervention was provided.On the right, a zsle-13-7 4 extended from the flow divider to the right common iliac artery (cia) ostium.The right iliac leg was then sealed with a zsle-16-74 in the distal right cia just proximal the internal iliac artery (iia) origin.The superior end of the zsle-16-90 was constrained to 9mm.At this point, because it was inside both the contralateral gate and zsle-13-74, it may have been constrained by redundant fabric from the zsle-13-74.Despite the abrupt narrowing, immediate downstream thrombus was absent.Mural thrombus began in the zsle-13-74 just proximal the zsle-16-90 and continued downstream until just past an acute 45 degree bend of the mid zsle-16-90.The zsle-16-90's diameter was 12mm x13mm at the bend.The contralateral gate and zsle-13-74 were not compressed or impinged upon.Impressions of the imaging reviewer: on the right non-occlusive mural thrombus developed in a widely patent straight segment that would not be expected to be thrombogenic based on turbulence.Furthermore, a stenosis caused by constraint of the zsle-13-74's superior end which should have been thrombogenic was thrombus free.This supports a systemic predisposition to thrombus formation.The patient reportedly was noncompliant with antiplatelet medication.A review of the device history record (dhr) for the final assembly and graft subassembly revealed no non-conformances documented for either of the associated device lots reviewed.The instructions for use (ifu) states the following in consideration of the reported failure mode: indications for use: the zenith spiral-z aaa iliac leg with the z-trak introduction system is indicated for use with the zenith aaa endovascular graft family of products, including the zenith flex aaa endovascular graft, zenith alpha abdominal endovascular graft, zenith low profile aaa endovascular graft, zenith renu ancillary graft, zenith fenestrated aaa endovascular graft, zenith universal distal body endovascular graft, zenith flex aui, or zenith branch iliac endovascular graft, during either a primary or a secondary procedure in patients who have adequate iliac/femoral access compatible with the required introduction systems.The graft is used in combination with these products for the endovascular treatment of abdominal aortic and aorto-iliac aneurysms.Warnings and precautions: pre-existing regions of stenosis/narrowing (less than approximately 20mm id in the aorta or 7 to 8 mm id in the iliacs) have been shown to increase the risk of a thromboembolic event.Patients with poor outflow or a hypercoagulable state (e.G., cancer) may be at an increased risk of thromboembolic event.All patients should be advised that endovascular treatment requires life-long, regular follow-up to assess their health and the performance of the endovascular graft.Potential adverse events: adverse events that may occur and/or require intervention include, but are not limited to: arterial or venous thrombosis and/or pseudoaneurysm, graft or native vessel occlusion.We have no past medical history that could shed light on any patient predisposition to thrombus formation.However, we are aware that the patient has a renal infarct that can increase risk of thrombus formation.We are also aware that the patient did not follow up with anti-coagulation therapy, as prescribed.Imaging was provided by the user facility and underwent expert image review.The imaging confirmed that the device was impinged and there was thrombus present.Imaging also reveals an acute bend that also increases risk of thrombus formation.And the imaging reviewer suggests there is evidence that the patient has a pre-disposition to thrombus formation.We are not aware of patient mobility, weight or inherited disorders that may have contributed to thrombus formation.There is no information regarding handling of the device.There is no information surrounding the procedure or any procedural difficulties.There are no planning and sizing sheets for review.The imaging reviewer does not suggest any undersizing or oversizing was observed.There is no evidence the device was not correctly placed.The complaint is confirmed based on image review.Cook has concluded human anatomy and the overlapping of 2 zsle devices contributed to this incident.Subsequently, as the device was constrained this probably contributed to thrombus formation as well as the aforementioned pre-dispositions.A quality engineer risk assessment was conducted to assess the risk of this failure mode and concluded a change is not required, thus no risk reduction activities are required at this time.Cook will continue to monitor for similar complaints.The appropriate personnel have been notified of this 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.
Event or Problem Description
There is no new event information to report.

• 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: 8091416
• Report Number: 1820334-2018-03269
• Device Sequence Number: 1279525
• Product Code: MIH
• UDI-Device Identifier: 10827002552392
• UDI-Public: (01)10827002552392(17)160701(10)4375912
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 05/28/2019

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: 07/01/2016
• Device Model Number: G55239
• Device Catalogue Number: ZSLE-16-90-ZT
• Device Lot Number: 4375912
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 05/03/2019
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 05/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR