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	G55237
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: tffb-32-111-zt, lot 7388630 and zsle-16-74-zt, lot 7333253.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
On (b)(6) 2017, the (b)(6) male patient underwent evar and received a tffb-32-111-zt, lot 7388630 (main body), a zsle-16-56-zt, lot 7478875 (right limb), and a zsle-16-74-zt, lot 7333253.There were no adverse events during the procedure and the patient outcome was reported to be fine.As reported, the patient has had pain on the right side since the beginning of (b)(6) 2019 but did not report this to his physician until his scheduled follow up in (b)(6) 2019.The computerized tomography (ct) scan revealed an occluded right iliac limb.The patient decided they did not want any intervention to correct the occlusion at this time.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.H6 - results code: appropriate term/code not available (4247) -device was found to be occluded.Investigation evaluation.A review of documentation including the complaint history, device history record, instructions for use (ifu) and quality control of the device, as well as a previously completed device failure analysis from a similar device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a complaint for a similar product experiencing a similar failure mode for mfg.Report reference #: 1820334-2019-01394 was referenced.The image review found that "the distal mainbody and left iliac leg were normal except for mild stenosis from mid left iliac leg mural thrombus." review of the imaging provided gave no evidence to suggest that the device was manufactured out of specifications.No significant tortuosity of the common iliac artery was observed.There was calcification within the common iliac artery around the left zsle, which could have been a contributing factor for the thrombus formation observed.The investigation concluded that a definitive cause for the thrombus formation could not be established.As both of these complaints involve an occluded zsle grafts, it is possible that the two events have a similar cause.Additionally, a document-based investigation evaluation was performed.Cook has concluded that sufficient controls and inspections are in place to prevent the release of non-conforming product related to the reported failure mode and that there is no evidence that suggests that the device was not manufactured to specifications.Design testing showed that the affected product is safe and effective for its intended use.It should be noted that a review of the device history record for lot 7478875 found no non-conformances that could have contributed to the failure mode.There were no other complaints reported for this lot number.Consequently, cook has concluded that there is no evidence that non-conforming product exists in house or in field.A review of the device's product labeling was completed.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: 1 device description 1.1.Zenith spiral-z aaa iliac leg.The zenith spiral-z aaa iliac leg should be used in conjunction with the zenith aaa main bodies (flex, fenestrated, low profile, alpha, universal distal body, and flex aui), branch, or renu and is part of a modular system consisting of multiple components, most typically a bifurcated main body and two iliac legs.2 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.4 warnings and precautions 4.1 general patients experiencing reduced blood flow through the graft limb and/or leaks may be required to undergo secondary interventions or surgical procedures.4.2 patient selection, treatment and follow-up pre-existing regions of stenosis/narrowing (less than approximately 20 mm id in the aorta or 7 to 8 mm id in the iliacs) have been shown to increase the risk of a thromboembolic event (e.G., graft limb occlusion).The potential for this increased risk in these patients may preclude placement of an endovascular graft.Dilation of these regions with a noncompliant balloon and/or stent placement may be necessary to help assure maintained graft patency and to reduce the risk of a thromboembolic event.Additionally, the completion angiogram (with stiff wire guides removed) should be reviewed carefully to determine if further treatment in these regions is necessary (e.G., adjunctive ballooning or stenting).Failure to remove the stiff wire guide prior to the angiogram could mask any limb kinking or narrowing that might occur when the wire guide is removed.Follow-up imaging should be carefully reviewed for narrowing within the graft leg.Patients with a graft leg lumen of less than approximately 5 mm id may be at increased risk of a thromboembolic event (e.G., graft limb occlusion).Reintervention (e.G., noncompliant ballooning or stenting in these regions) should be considered to help assure maintained graft patency and to reduce the risk of a thromboembolic event.-patients with poor outflow or a hypercoagulable state (e.G., cancer) may be at an increased risk of a thromboembolic event.4.5 implant procedure excessive overlap 10 mm above the main body bifurcation may increase the risk of limb thrombosis.5 adverse events 5.2 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 claudication (e.G., buttock, lower limb) embolization (micro and macro) with transient or permanent ischemia or infarction endoprosthesis: improper component placement; incomplete component deployment; component migration; component separation from another graft component; suture break; occlusion; infection; stent fracture; graft material wear; dilation; erosion; puncture; perigraft flow; and corrosion graft or native vessel occlusion 11 directions for use 11.1 zenith spiral-z aaa iliac leg system (fig 2) 11.1.4 contralateral iliac leg placement and deployment 3.Introduce the contralateral iliac leg delivery system into the artery.Advance slowly until at least one stent of the iliac leg graft overlaps within the main body and not past the radiopaque marker band positioned 30 mm from the proximal end of the iliac leg graft inside the contralateral limb of the main body.4.Confirm position of distal end of the iliac leg graft.Reposition the iliac leg graft if necessary to ensure internal iliac patency, a minimum overlap of one stent, and a maximum overlap of 30 mm within the main body endovascular graft.11.1.5 ipsilateral iliac leg placement and deployment 2.Advance slowly until the ipsilateral iliac leg graft overlaps a minimum of one stent inside the ipsilateral limb of the main body.The complaint was able to be confirmed based on customer testimony.Based on the information provided, no product returned, and the results of our investigation, a definitive root cause could not be established.Appropriate measures were conducted to address this failure mode.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.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
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: 8595830
• Report Number: 1820334-2019-01085
• Device Sequence Number: 19381202
• Product Code: MIH
• UDI-Device Identifier: 10827002552378
• UDI-Public: (01)10827002552378(17)191205(10)7478875
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2019

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: 12/05/2019
• Device Model Number: G55237
• Device Catalogue Number: ZSLE-16-56-ZT
• Device Lot Number: 7478875
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 05/09/2019
• Supplement Report FDA Received Date: 10/25/2019
• 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: Other
• Patient Age: 71 YR