MAUDE Adverse Event Report: COOK INC ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number N/A

Device Problems Material Separation (1562); Activation Failure (3270)

Patient Problem Insufficient Information (4580)

Event Date 12/27/2023

Event Type  Injury  

Event Description

A patient underwent a repair procedure for a failed competitor's graft.The zenith flex aaa endovascular graft bifurcated main body was modified and used off-label.The patient had tortuous vessels and had significant tortuosity of the distal aorta, iliac arteries and/or femoral arteries.The angulation of the aneurysm neck relative to the suprarenal aorta as well as the angulation of the aneurysm neck relative to the long axis of the aaa were within instructions for use (ifu) limits.It is unknown if the patient was prescribed any regimen of anticoagulant or antiplatelet medication before the index evar procedure where the competitor's graft was placed.During the procedure to place the modified zenith flex aaa endovascular graft bifurcated main body, the cook graft delivery system was rotated together per ifu.The device was able to be landed in the target zone.The alternative trigger wire release method was utilized.The cook trigger wires broke at the delivery system (teal) handle on both the top cap wire and the distal trigger wire.Therefore, they could not be removed from the handle.The physician had to abort the procedure and convert to an open surgical repair.The physician intended to remove the competitor's graft during the open surgical repair.It is unknown if this was completed.The open repair resolved the issue.

Manufacturer Narrative

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.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.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 Description

In additional information received on 11jan2024, it was reported that as of (b)(6) 2023, the patient was still alive post explant procedure.There has been no known change with the patient.To modify the graft for the physician modified endovascular graft (pmeg) procedure, the physician deployed the graft on the back table, burned and sutured holes and re-sheathed the device.It was confirmed that the delivery system was not modified during the procedure but was "chopped up" while troubleshooting broken trigger wires to enable graft to be fully deployed.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Correction: h6 (annex a).Investigation ¿ evaluation.Cook was informed that the trigger wires broke at the handle during deployment for a zenith flex aaa endovascular graft bifurcated main body (tffb) that had been modified prior to the introduction into the patient.The 66-year-old male patient had tortuous vessels and had significant tortuosity of the distal aorta, iliac arteries and/or femoral arteries.The angulation of the aneurysm neck relative to the suprarenal aorta as well as the angulation of the aneurysm neck relative to the long axis of the aaa were within instruction for use (ifu) limits.The patient had a previously implanted competitor graft that failed (failure unknown) and required revision.Prior to the endovascular aortic repair procedure (evar) on (b)(6) 2023, the physician modified the zenith flex aaa endovascular graft bifurcated main body.To modify the graft, the physician deployed the graft on the back table, burned and sutured holes and then re-sheathed the device.It was confirmed that the delivery system was not modified during the graft modification.The physician modified endovascular graft (pmeg) was intended to be placed during the evar procedure to repair the failed competitor¿s graft.During the deployment of the pmeg zenith flex aaa endovascular graft bifurcated main body the delivery system was rotated together per (ifu).The device was able to be landed in the target zone.The alternative trigger wire release method was utilized.However, the graft would not deploy.The trigger wires broke at the teal handle on both the top cap and the distal trigger wire.The trigger wires could not be removed.The physician had to abort the procedure at this point and convert the procedure to an open repair.During the open repair, the physician intended to remove the previously placed competitor¿s graft, but this was not confirmed as the cook district manager left before the case was completed.The delivery system of the pmeg zenith flex aaa endovascular graft bifurcated main body was "chopped up" while troubleshooting broken trigger wires to enable graft to be fully deployed.The open repair resolved the issue.The patient was prescribed heparin after the placement of the grafts.It is unknown if this was after the placement of the competitor¿s graft or after the open repair.As of (b)(6) 2023, the patient was still alive post explant procedure and there has been no known change with the patient.Reviews of the complaint history, device history record (dhr), drawing, instructions for use (ifu), manufacturing instructions, quality control procedures, and specifications of the device, as well as a visual inspection, were conducted during the investigation.The complainant returned one used device (tffb-36-95-zt) for evaluation.The gray pusher was separated into two pieces.The graft was attached to the top cap with the trigger wire.There was a trigger wire coiled up and attached to the long leg.The graft (tffbg-36-95) had been altered.The threaded cannula was no longer attached to the handle as the handle was missing.Due to the extensive damage of the delivery system the trigger wires could not be measured.Additionally, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.In response to this complaint.Cook also completed a dhr review and records 0 non-conformances.The dhr for the graft sub-assembly was reviewed and records 0 non-conformances.The dhr for the sewn graft from vendor approved was reviewed and records 0 non-conformances.The dhr for the graft kit sub-assembly was reviewed and records 0 non-conformances.A database search for complaints on the reported lot found no additional complaints reported from the field.Evidence provided by the complaint facility, device history record, complaint history, and manufacturing documents 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.Cook also reviewed product labeling.The product ifu, t_zaaaf_rev5 ¿zenith flex aaa endovascular graft with the z-trak introduction system¿ provides the following information to the user related to the reported failure mode: 1.2 main body delivery system the zenith flex aaa endovascular graft main body is shipped preloaded onto the z-trak introduction system.It has a sequential deployment method with built-in features to provide continuous control of the endovascular graft throughout the deployment procedure.The z-trak introduction system is designed for precise positioning and allows readjustment of the final graft position before deployment of the barbed suprarenal stent.The main body graft delivery system uses an 18, 20 or 22 french z-trak introduction system.Dual trigger-wire release mechanisms lock the endovascular graft onto the delivery system until released by the physician.All systems are compatible with a.035 inch wire guide.For added hemostasis, the captor hemostatic valve can be loosened or tightened for the introduction and/or removal of ancillary devices into and out of the sheath.The main body delivery systems feature a flexor introducer sheath.The main body delivery systems feature a flexor introducer sheath which resists kinking and is hydrophilically coated.Both features are intended to enhance trackability in the iliac arteries and abdominal aorta.4 warnings and precautions 4.1 general ¿ read all instructions carefully.Failure to properly follow the instructions, warnings and precautions may lead to serious consequences or injury to the patient.4.2 patient selection, treatment and follow-up ¿ the zenith flex aaa endovascular graft is designed to treat aortic neck diameters no smaller than 18 mm and no larger than 32 mm.The zenith flex aaa endovascular graft is designed to treat proximal aortic necks (distal to the lowest renal artery) of at least 15 mm in length.Iliac artery distal fixation site greater than 10 mm in length and 7.5 - 20 mm in diameter (measured outer wall to outer wall) is required.These sizing measurements are critical to the performance of the endovascular repair.¿ key anatomical elements that may affect successful exclusion of the aneurysm include severe proximal neck angulation (>60 degrees for infrarenal neck to axis of aaa or >45 degrees for suprarenal neck relative to the immediate infrarenal neck); short proximal aortic neck (<15 mm); an inverted funnel shape (greater than 10% increase in diameter over 15 mm of proximal aortic neck length); and circumferential thrombus and/or calcification at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface.In the presence of anatomical limitations, a longer neck may be required to obtain adequate sealing and fixation.Irregular calcification and/or plaque may compromise the attachment and sealing at the fixation sites.Necks exhibiting these key anatomical elements may be more conducive to graft migration or endoleak.¿ adequate iliac or femoral access is required to introduce the device into the vasculature.Access vessel diameter (measured inner wall to inner wall) and morphology (minimal tortuosity, occlusive disease and/or calcification) should be compatible with vascular access techniques and delivery systems of a 16 french to 22 french vascular introducer sheath.Vessels that are significantly calcified, occlusive, tortuous, or thrombus-lined may preclude placement of the endovascular graft and/or may increase the risk of embolization.A vascular conduit technique may be necessary to achieve success in some patients.¿ the safety and effectiveness of the zenith flex aaa endovascular graft with the z-trak introduction system has not been evaluated in the following patient populations: - revision of previously placed endovascular grafts 4.5 implant procedure ¿ do not bend or kink the delivery system.Doing so may cause damage to the delivery system and the zenith flex aaa endovascular graft.¿ to avoid any twist in the endovascular graft, during any rotation of the delivery system, be careful to rotate all of the components of the system together (from outer sheath to inner cannula) ¿ do not attempt to re-sheath the graft after partial or complete deployment.¿ do not continue advancing any portion of the delivery system if resistance is felt during advancement of the wire guide or delivery system.Stop and assess the cause of resistance: vessel, catheter or graft damage may occur.Exercise particular care in areas of stenosis, intravascular thrombosis or in calcified or tortuous vessels.5.2 potential adverse events adverse events that may occur and/or require intervention include, but are not limited to: ¿ aneurysm rupture and death ¿ aortic damage, including perforation, dissection, bleeding, rupture and death ¿ endoprosthesis: improper component placement; incomplete component deployment; component migration; suture break; occlusion; infection; stent fracture; graft material wear; dilatation; erosion; puncture; perigraft flow; barb separation and corrosion 7 patient selection and treatment 7.1 individualization of treatment the risks and benefits should be carefully considered for each patient before use of the zenith flex aaa endovascular graft.Additional considerations for patient selection include but are not limited to: ¿ co-morbidities (e.G., cardiac, pulmonary or renal insufficiency prior to surgery, morbid obesity) ¿ patient's anatomical suitability for endovascular repair ¿ non-aneurysmal infrarenal aortic segment (neck) proximal to the aneurysm: ¿ with a length of at least 15 mm, ¿ with a diameter measured outer wall to outer wall of no greater than 32 mm and no less than 18 mm, ¿ with an angle less than 60 degrees relative to the long axis of the aneurysm, and ¿ with an angle less than 45 degrees relative to the axis of the suprarenal aorta ¿ iliac artery distal fixation site greater than 10 mm in length and 7.5 to 20 mm in diameter (measured outer wall to outer wall) ¿ freedom from significant femoral/iliac artery occlusive disease that would impede flow through the endovascular graft the final treatment decision is at the discretion of the physician and patient.Based on the information provided, inspection of the returned device, and the results of the investigation, a definitive conclusion could not be determined.It is likely the use of the device off-label was a contributing factor to the failure, as well as patient condition/anatomy.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.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 Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
• Type of Device: 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: 18477506
• MDR Text Key: 332492693
• Report Number: 1820334-2024-00045
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002484327
• UDI-Public: (01)10827002484327(17)250714(10)15558747
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/01/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: TFFB-36-95-ZT
• Device Lot Number: 15558747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/27/2023
• Initial Date FDA Received: 01/09/2024
• Supplement Dates Manufacturer Received: 01/11/2024; 03/06/2024
• Supplement Dates FDA Received: 01/22/2024; 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male