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 Fracture (1260); Material Separation (1562)

Event Date 01/02/2023

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Device assumed to be a zenith flex aaa endovascular graft bifurcated main body.Rpn unknown at this time.Date of implant: 2012.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

It was reported that a zenith flex bifurcated main body graft "disintegrated." the graft was initially placed as part of a clinical trial in 2012 at the university of pennsylvania in a now 81-year-old male.Additionally, one of the struts at the top of the device separated and remains embedded in the patients arterial wall.The patient presented to the hospital with symptoms related to the aneurysm growth.That separated strut is now covered by a realignment procedure that was performed using a competitors device.No other adverse effects were reported for this incident.Additional information regarding the event has been requested but is currently unavailable.

Event Description

Additional information was provided on 09feb2023 regarding the devices implanted in the patient.

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.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Correction: h6 (annex a).Investigation ¿ evaluation.On 03jan2023, dr.(b)(6) hospital, philadelphia, pennsylvania reported a required reintervention procedure for a zenith flex aaa endovascular graft bifurcated main body (rpn: tffb-36-95-zt; lot: #3127934) that was fractured.In 2012, dr.(b)(6) performed the initial implant during an endovascular aortic repair (evar) in an 81-year-old patient at the university of pennsylvania as a part of the ¿preserve trial".During the initial procedure, a zenith flex aaa endovascular graft bifurcated main body and an iliac branch device on the left common were implanted.It is unknown if the patient had any pre-existing conditions or comorbidities and if the patient was compliant with follow-up protocol per the ifu.On (b)(6) 2023, the patient presented to the (b)(6) hospital with symptoms of aneurysm growth.It was reported that the internal iliac study stent had disintegrated/blew out.Dr.(b)(6) performed an urgent reintervention procedure (tbranch) where competitor¿s devices (vbx and gore viabahn¿s) were used for realignment and to further extend the seal zone.It was discovered that one of the top struts of the zenith flex aaa endovascular graft bifurcated main body had broken.The broken piece was left inside/embedded in the patent¿s aortic wall and was covered by the devices used for realignment.Reviews of documentation including the complaint history, device history record (dhr), drawings, instructions for use (ifu), manufacturing instructions, quality control procedures, and specifications of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, still images of the case were provided for review.The image reviewer indicated that the fixation stent of the main body graft was fractured on one side but was unable to confirm if the stent was flaring open due to a large aneurysmal sac.The reviewer stated this is doubtful.The image reviewer also noted that there were no other anatomical concerns noted on the images provided.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.Cook also reviewed the device history record (dhr).The dhrs for the final product lot 3127934 and all related subassembly lot numbers reported zero non-conformances.Additionally, no other complaints have been reported.Therefore, cook concludes that the complaint device was manufactured per specification.There is no evidence of nonconforming devices in house or in the field.Cook also reviewed product labeling.The device was packaged with ifu t_zaaaf_rev5.The ifu includes the following, warnings, precautions, and instructions for proper placement of the device.4 warnings and precautions: 4.1 general: ¿ additional endovascular interventions or conversion to standard open surgical repair following initial endovascular repair should be considered for patients experiencing an enlarging aneurysm, unacceptable decrease in fixation length (vessel and component overlap) and/or endoleak or migration may lead to aneurysm rupture.4.2 patient selection, treatment and follow-up: ¿ 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 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.¿ successful patient selection requires specific imaging and accurate measurements; please see section 4.3, pre-procedure measurement techniques, and imaging.4.4 device selection: ¿ strict adherence to the zenith flex aaa endovascular graft ifu sizing guide is strongly recommended when selecting the appropriate device size (tables 10.5.1 through 10.5.2).Appropriate device oversizing has been incorporated into the ifu sizing guide.Sizing outside of this range can result in endoleak, fracture, migration, device infolding or compression.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.¿ repositioning the stent graft distally after partial deployment of the covered proximal stent may result in damage to the stent graft and/or vessel injury.¿ repositioning the stent graft distally after partial deployment of the covered proximal stent may result in damage to the stent graft and/or vessel injury.¿ fluoroscopy should be used during introduction and deployment to confirm proper operation of the delivery system components, proper placement of the graft, and desired procedural outcome.¿ the zenith alpha abdominal endovascular graft incorporates a suprarenal stent with fixation barbs.Exercise extreme caution when manipulating interventional and angiographic devices in the region of the suprarenal stent.¿ avoid damaging the graft or disturbing graft positioning after placement in the event re-instrumentation (secondary intervention) of the graft is necessary.5 potential adverse events: 5.2 potential adverse events: ¿ aneurysm enlargement.¿ aneurysm rupture and death.¿ claudication (e.G., buttock, lower limb).¿ endoleak.¿ 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; component separation.¿ surgical conversion to open repair.7 patient selection and treatment: 7.1 individualization of treatment: additional considerations for patient selection include but are not limited to: ¿ patient¿s age and life expectancy.¿ comorbidities (e.G., cardiac, pulmonary, or renal insufficiency prior to surgery, morbid obesity).¿ patient¿s suitability for open surgical repair.¿ patient¿s anatomical suitability for endovascular repair.¿ ability to tolerate general, regional, or local anesthesia.¿ iliofemoral access vessel size and morphology (minimal thrombus, calcification and/or tortuosity) should be compatible with a 16 fr (6.0 mm od) or 17 fr (6.5 mm od) vascular introducer sheath.8 patient counseling information: ¿ patients should be counseled on the importance of adhering to the follow-up schedule, both during the first year and at yearly intervals thereafter.Patients should be told that regular and consistent follow-up is critical part of ensuring the ongoing safety and effectiveness of endovascular treatment of aaas.At a minimum, annual imaging and adherence to routine postoperative follow-up requirements is required and should be considered a lifelong commitment to the patient¿s health and well-being.Physicians should refer patients to the patient guide regarding risks occurring during or after implantation of the device.Procedure-related risks include cardiac, pulmonary, neurologic, bowel and bleeding complications.Device-related risks include occlusion, endoleak, aneurysm enlargement, fracture, potential for reintervention and open surgical conversion, rupture, and death (see section 5, potential adverse events).The physician should complete the patient id card and give it to the patient so that he/she can carry it with him/her at all times.The patient should refer to the card anytime he/she visits additional health practitioners, particularly for any additional diagnostic procedures (e.G., mri).12 imaging guidelines and postoperative follow-up: 12.1 general: ¿ the long-term performance of this endovascular graft has not yet been established.All patients should advise that endovascular treatment requires lifelong, regular follow-up to assess their health and the performance of their endovascular graft.Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysms or changes in the structure or position of the endovascular graft) should receive additional follow-up.¿ physicians should evaluate patients on an individual basis and prescribe their follow-up relative to the needs and circumstances of each individual patient.The recommended imaging schedule is presented in table 11.1.1.This schedule continues to be the minimum requirement for patient follow-up and should be maintained even in the absence of clinical symptoms (e.G., pain, numbness, weakness).Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysms or changes in the structure or position of the stent graft) should receive follow-up at more frequent intervals.¿ the combination of contrast and non-contrast ct imaging provides information on aneurysm diameter change, endoleak, patency, tortuosity, progressive disease, fixation length and other morphological changes.Based on the information provided, review of provided still images, and the results of the investigation, cook could not determine a definitive cause for the reported failure.It is possible that disease progression may have contributed to the failure as it was reported an intervention had to be performed due to the aneurysm growth, but that cannot be confirmed from the still images provided.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: 16164869
• MDR Text Key: 307466110
• Report Number: 1820334-2023-00029
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002484327
• UDI-Public: (01)10827002484327(17)140201(10)3127934
• 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
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/08/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2014
• Device Model Number: N/A
• Device Catalogue Number: TFFB-36-95-ZT
• Device Lot Number: 3127934
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2023
• Initial Date FDA Received: 01/13/2023
• Supplement Dates Manufacturer Received: 02/09/2023; 04/18/2023
• Supplement Dates FDA Received: 02/13/2023; 05/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2012
• 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
• Treatment: COOK BILATERAL INTERNAL ILIAC LEG GRAFTS; COOK BRANCHED INTERNAL ILIAC GRAFT; COOK, TFLE-16-39-ZT LOT 2612233; COOK, ZSLE-20-56-ZT LOT 3139050
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male