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	G55245
Medical Device Problem Codes	Partial Blockage (1065); Obstruction of Flow (2423)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
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 a zenith flex with spiral-z technology aaa endovascular graft iliac leg occluded.During a routine follow-up on (b)(6) 2018, a right limb occlusion was noted (though the user has currently not confirmed which graft was placed on the right side).On (b)(6) 2021, ultrasound identified all of the implanted grafts to be occluded.The patient will not be treated.An additional event regarding this patient is also reported under patient identifier: (b)(6).
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Additional information: a3, b5, b7.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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
In additional information received on 07sep2021, it was reported that this patient has had issues regarding the occlusion for the last nine months.The diagnosis was missed initially and was made during routine follow-up imaging.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown or unavailable.Investigation ¿ evaluation.On (b)(6) 2021 cook became aware of an incident where a right limb occlusion was noted in the complaint device zenith flex with spiral-z technology aaa endovascular graft iliac leg "rpn: zsle-24-56-zt, lot: 6830174".The issue was originally reported by a physician at health sciences centre in canada.No treatment was reported by the complaint facility.A review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device, were conducted during the investigation.The complainant did not return the complaint device to cook for investigation.The complainant was unable to provide photos of the complaint device or relevant medical imaging for review.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.A review of the device history record revealed that there were no failure related nonconformance reported on lot number 6830174.A complaint search revealed no other complaints associated to the lot number 6830174.Device history file was reviewed and risk controls are in place for this failure mode.Cook also reviewed product labeling.The product instructions for use 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: "patients experiencing reduced blood flow through the graft limb and/ or leaks may be required to undergo secondary interventions or surgical procedures.Pre-existing regions of stenosis/narrowing (less than approximately 20 mm id in the aorta or 7 to 8 mm id in the iliac's) 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.Patient 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." directions for use: section 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." 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).Graft or native vessel occlusion".Evidence provided by the complaint facility, complaint history, manufacturing documents, and verification testing, suggests that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.Based on the information provided, no inspection of returned product and the results of the investigation, a definitive cause could not be established.However, it should be noted that aneurysm growth is a known inherent risk of using this device.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Correction: b1, b2, h1, h6 (annex e), h6 (annex f), h6 (annex a).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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 or that a death or serious injury occurred; nor is it admission 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
Additional information was provided on 04jan2024 indicating that the patient required a axillobifemoral bypass for an occluded aorta on (b)(6) 2021.An additional report for this patient identifier (b)(6) was submitted under mdr #1820334-2021-02000.

• 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
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 12331962
• Report Number: 1820334-2021-01999
• Device Sequence Number: 11451653
• Product Code: MIH
• UDI-Device Identifier: 10827002552453
• UDI-Public: (01)10827002552453(17)190329(10)6830174
• Combination Product (Y/N): N
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/29/2024

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: 03/29/2019
• Device Model Number: G55245
• Device Catalogue Number: ZSLE-24-56-ZT
• Device Lot Number: 6830174
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/03/2021
• Supplement Date Received by Manufacturer: 09/07/2021; 11/24/2021; 01/04/2024
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 09/21/2021; 12/16/2021; 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COOK ZIMB-32-128; COOK ZISL-16-59; COOK ZSLE-24-39-ZT; COOK ZIMB-32-128; COOK ZISL-16-59; COOK ZSLE-24-39-ZT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male