MAUDE Adverse Event Report: COOK INC ZENITH RENU AAA ANCILLARY GRAFT CONVERTER; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number G55388

Device Problems Contamination (1120); Fluid/Blood Leak (1250)

Patient Problems Bacterial Infection (1735); Pneumonia (2011)

Event Date 12/19/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter occupation: cook sales representative.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported that an endoleak and bacterial infection occurred on a zenith renu aaa ancillary graft converter following an endovascular aneurysm repair (evar) procedure.On (b)(6) 2021, the patient was "coding" during the deployment of the graft converter device.The device was deployed lower in the anatomy than was planned.On (b)(6) 2021, an angiogram was completed that showed an endoleak.On (b)(6) 2021, an extension graft was placed to seal the endoleak.It was noted the patient had pneumonia and that the graft converter had a bacterial infection.The graft was scheduled for explantation on (b)(6) 2021.No other adverse effects were reported for this incident.

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.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

Additional information was provided on 17feb2022.The patient had slight infra-renal neck angulation that was estimated to be between 10 to 20 degrees.No significant tortuosity was present in the distal aorta, iliac arteries and/or femoral arteries.During the index procedure on (b)(6) 2021, the patient received three cook devices including a right iliac leg graft, a left iliac leg graft, and a zenith renu aaa ancillary graft converter (ax1-2-32-113-zt).A cook coda balloon (46) was also used during the procedure.During placement of the graft converter, the physician was unable to land the device as intended resulting in a type 1a endoleak.During deployment of the graft converter, the wire guide was extended just distal to the aortic arch.The proximal/top stent trigger wire released prior to advancement of the top cap.No difficulties were experienced with the top cap removal.The distal/ipsilateral limb trigger wire was not released prior to advancement of the top cap.It was noted the sterile field was managed by having the scrubbed personnel tend to the patient and the non-scrubbed staff maintaining distance form the sterile field.After placement of the grafts the patient was prescribed antibiotics.No specifics regarding the prescription/dosage were provided.Two months after the index procedure, an extension cuff was placed to address the type 1a endoleak.The type 1a endoleak was resolved after the reintervention procedure.Imaging is not available for this event.

Event Description

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

Manufacturer Narrative

Investigation ¿ evaluation.(b)(6) hospital informed cook of an event with a 64-year-old male patient with a type 1a endoleak.The complaint device was zenith renu aaa ancillary graft converter rpn: ax1-2-32-113-zt (product lot 9881288).The initial procedure was on (b)(6) 2021, and the following devices were implanted: ax1-2-32-113-zt (product lot 9881288), rpn: zsle-13-90-zt (product lot 10205942), rpn: zsle-11-56-zt (product lot 13801660).During the procedure, the physician was not able to land the device in the intended location and a type 1a endoleak was present.The wire guide was extended distal to the aortic arch.The proximal top stent trigger wire released prior to advancement of the top-cap.No difficulties were experienced with the top cap removal.The distal ipsilateral limb trigger wire was not released prior to advancement of the top cap.The rep was present during the procedure and stated the sterile field was maintained throughout the procedure.On (b)(6) 2021, the physician placed a cuff to seal off the endoleak with rpn: esbe-32-58 (product lot 14231406).However, it was reported the patient had pneumonia and the graft had a bacterial infection.The patient had a slight infra-renal neck angulation, estimated to be 10 to 20 degrees and no significant tortuosity was present.After placement of the grafts, the patient was prescribed an unknown medication.A review of the complaint history, device history record, drawing, 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 to cook for analysis.Medical imaging was not provided for review.Additionally, a document based investigation evaluation was performed.Review of the device master record (dmr) concluded that appropriate inspections are in place relative to the reported device failures.A review of the device history record (dhr) was also conducted as a part of the investigation to check for failure related nonconformances and additional complaints.The dhr for the complaint lot found no nonconformances.Graft subassembly lot sa8866992 had one nonconformance, but it was reworked and re-inspected prior to further processing.There were no additional complaint on different devices having the same lot number.The device was packaged with ifu t_raaaz_rev1.The ifu includes the following, warnings, precautions, and instructions for proper placement of the device.4 warnings and precautions: 4.1 general: ¿ patients should be counseled on the importance of adhering to the follow-up schedule, both during the first year and at yearly intervals thereafter.More frequent follow-up may be appropriate for all patients receiving the zenith renu aaa ancillary graft until stability of the zenith renu aaa ancillary graft, pre-existing graft, and aneurysm has been established.¿ additional endovascular interventions or conversion to standard open surgical repair following initial endovascular repair should be considered for patients experiencing an enlarging aneurysm, unacceptable fixation length (both the vessel and component overlaps) and/or endoleak.An increase in aneurysm size and/or persistent endoleak or migration may lead to aneurysm rupture.¿ patients experiencing reduced blood flow through the graft and/or leaks may be required to undergo secondary interventions or surgical procedures.4.2 patient selection, treatment and follow-up: ¿ key anatomical elements that may affect successful exclusion of the aneurysm include sever 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 sealing length (<15 mm); an inverted funnel shape (>10% increase in diameter over 15 mm of proximal aortic sealing length); and circumferential thrombus and/or calcification at the arterial implantation sites, specifically the proximal aortic sealing zone and distal iliac artery interface (if using zenith renu aaa converter device).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.Proximal aortic sealing zones exhibiting these key anatomical elements may be more conducive to graft migration or endoleak.¿ multiple large, patent lumbar arteries, mural thrombus and a patent inferior mesenteric artery may all predispose a patient to type ii endoleaks.Patients with uncorrectable coagulopathy may also have an increased risk of type ii endoleak or bleeding complications.4.3 pre-procedure measurement techniques and imaging: lengths: ¿ the long-term performance of endovascular grafts has not yet been established.All patients should be advised that endovascular treatment requires life-long, regular follow-up to assess their health and the performance of their endovascular graft.Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysm or changes in the structure or position of the endovascular graft) should receive enhanced follow-up.Specific follow-up guidelines are described in section 12, imaging guidelines and postoperative follow-up.4.4 device selection: strict adherence to the zenith renu aaa ancillary 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: ¿ inaccurate placement and/or incomplete sealing of the zenith renu aaa ancillary graft within the vessel may result in increased risk of endoleak, migration or inadvertent occlusion of the renall or internal iliac arteries.Renal artery patency must be maintained to prevent/reduce the risk of renal failure and subsequent complications.¿ minimize handling of the constrained endoprosthesis during preparation and insertion to decrease the risk of endoprosthesis contamination and infection.¿ 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.¿ before deployment of the suprarenal stent, verify that the position of the access wire guide extends just distal to the aortic arch.5 potential adverse events: ¿ aneurysm enlargement.¿ aneurysm rupture and death.¿ claudication (e.G., buttock, lower limb).¿ endoleak.¿ endoprosthesis: improper placement; incomplete deployment; migration; component separation; suture break; occlusion; infection; stent fracture; graft material wear; dilatation; erosion; puncture; perigraft flow; barb separation and corrosion.¿ infection of aneurysm, device, or access site, including abscess formation, transient fever, and pain.7 patient selection and treatment: ¿ co-morbidities (e.G., cardiac, pulmonary, or renal insufficiency prior to surgery, morbid obesity).¿ patient¿s anatomical suitability for endovascular repair.¿ ability to tolerate general, regional, or local anesthesia.8 patient counseling information: ¿ all patients should be advised that endovascular treatment requires life-long, 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 component) should receive enhanced follow-up.Specific follow-up guidelines are described in section 12, imaging guidelines and postoperative follow-up.¿ procedure-related risks include cardiac, pulmonary, neurologic, bowel and bleeding complications.Device-related risks include occlusion, endoleak, migration, 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 i.D.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: ¿ all patients should be advised 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 component) should receive enhanced follow-up.¿ patients should be counseled on the importance of adhering to the follow-up schedule, both during the first year and at least yearly intervals thereafter.More frequent follow-up may be appropriate for all patients receiving the zenith renu aaa ancillary graft until stability of the zenith renu aaa ancillary graft, pre-existing graft, and aneurysm has been established.Patients exhibiting endoleak after treatment with the zenith renu aaa ancillary graft should be monitored closely, particularly those with either type i or type iii endoleak, which can result in aneurysm growth/rupture.¿ 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 12.1.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.¿ duplex ultrasound imaging may provide information on aneurysm diameter change, endoleak, patency, tortuosity, and progressive disease.In this circumstance, a non-contrast ct should be performed to use in conjunction with the ultrasound.Ultrasound may be a less reliable and sensitive diagnostic method compared to ct.12.6 additional surveillance and treatment: ¿ aneurysms with type i endoleak.¿ aneurysms with type iii endoleak.After review of the ifu, cook has concluded the device labeling contains appropriate warnings, precautions and instructions to the user related to the reported failures.Evidence provided by the complaint facility, device history record, complaint history, manufacturing documents, and verification testing, suggests that the device was manufactured to specification.There is no evidence of nonconforming devices in house or in the field.A definitive cause for both the 1a endoleak and bacterial infection could not be established.And while the cause of the 1a endoleak in this case is not known, device placement may have contributed.The appropriate internal personnel have been notified.Per the 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.

• Brand Name: ZENITH RENU AAA ANCILLARY GRAFT CONVERTER
• 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: 13169784
• MDR Text Key: 283259143
• Report Number: 1820334-2022-00021
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002553887
• UDI-Public: (01)10827002553887(17)220723(10)9881288
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/03/2022

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: 07/23/2022
• Device Model Number: G55388
• Device Catalogue Number: AX1-2-32-113-ZT
• Device Lot Number: 9881288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/19/2021
• Initial Date FDA Received: 01/05/2022
• Supplement Dates Manufacturer Received: 02/17/2022; 05/09/2022
• Supplement Dates FDA Received: 03/14/2022; 06/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2019
• 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 CODA BALLOON (46).; ZSLE-11-56-ZT ILIAC LEG GRAFT.; ZSLE-13-90-ZT ILIAC LEG GRAFT.
• Patient Outcome(s): Required Intervention; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male