MAUDE Adverse Event Report: COOK INC ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number G48452

Device Problems Difficult to Remove (1528); Material Separation (1562); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2022

Event Type  Injury  

Manufacturer Narrative

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 a (b)(6), male patient required a zenith flex aaa endovascular graft iliac leg for an endovascular aortic repair procedure.After the delivery system was advanced to the aorta and the graft was released, the user observed under x-ray that the tip of the delivery system was stuck to the first stent of the graft.The doctor subsequently removed the delivery system from the patient.However, upon removal the tip of the delivery system pulled the stent material out of the body.Following angiography, the delivery system was found to be shortened.A photo provided by the user showed damage to the delivery system.Another leg graft was placed to complete the procedure successfully.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 07feb2022.The right femoral approach had no calcification or tortuosity.The angle was reportedly normal.The right iliac leg graft was released smoothly.When the delivery system was withdrawn, the tip of the delivery system got stuck to the first stent of the right iliac leg graft and could not be detached.After repeated attempts to remove the delivery system, the delivery system could not be removed and the procedure was converted to an open procedure.The doctor was able to forcibly disconnect the tip of the delivery system from the metal stent of the right iliac leg graft.Upon removal and inspection, the tip of the delivery system was described as not smooth.

Manufacturer Narrative

Investigation ¿ evaluation.Chengdu chengfu medical equip.Co informed cook of an event involving a zenith flex aaa endovascular graft iliac leg tfle-12-107-zt (product lot 14148590).It was reported that the delivery system was damaged.During the procedure, the distal tip of the device got caught on the first keel of the stent and could not be detached.After repeated attempts, the tip could not be removed, and the physician had to transfer to open procedure to remove the stent.Another graft was implanted and released successfully.A section of the device did not remain inside the patient¿s body.It was reported there was no calcification present along the path of delivery of the graft.The patient did not require any additional procedures due to this occurrence and did not experience any adverse effects.Reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device, as well as a visual inspection, were conducted during the investigation.The complaint device was returned to cook for investigation.Physical examination of the device showed the stent was received in damaged condition, one blue suture was noted on the stent.The shaft of the delivery system was buckled and bunched up down towards the distal end approximately 13cm in length.Medical imaging was not provided for review.However, there were six short videos and four still pictures provided, and they were reviewed by an expert reviewer.The review noted the first stent of the tfle device does appear to in-fold at the top following attempts to remove the delivery system.Anatomically, there does not appear to be any challenges in the proximally end to prevent the delivery system from being removed as expected.The right external iliac artery appears tortuous, but this would cause more challenges with introduction than removal of delivery system.Additionally, a document based investigation evaluation was performed.After review of the device master record, it was concluded that appropriate inspections are in place relative to the reported device failure.Cook reviewed the device history record (dhr) for the final product and subassembly work orders.The final product lot 14148590, graft lot sa13696817, and the tapered tip subassembly lot sa10062231 had zero nonconformance¿s reported.70262-a-1 subassembly lot sa13902946 had one non-conformance reported, but it was reworked and re-inspected prior to further processing.There are two complaints against product lot 14148590.One complaint is for the tip of the stent being stuck to the first keel of the stent and the other is for the delivery system being damaged.No other complaints have been reported.The two complaints are on the same device that experienced two failures during the same procedure.Both failures on the device are captured under this report.Therefore, cook concludes that the complaint device was manufactured per specification.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.An increase in aneurysm size and/or persistent endoleak or migration may lead to aneurysm rupture.¿ 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: ¿ 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.¿ the zenith flex aaa endovascular graft with the z-trak introduction system is not recommended in patients who cannot tolerate contrast agents necessary for intraoperative and postoperative follow-up imaging.All patients should be monitored closely and checked periodically for a change in the condition of their disease and the integrity of the endoprosthesis.¿ 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 complication.¿ successful patient selection requires specific imaging and accurate measurements; please see section 4.3 pre-procedure measurement techniques and imaging.4.3 pre-procedure measurement techniques and imaging: ¿ clinical experience indicates that contrast-enhanced spiral computed tomographic angiography (cta) with 3-d reconstruction is the strongly recommended imaging modality to accurately assess patient anatomy prior to treatment with the zenith flex aaa endovascular graft.If contrast-enhanced spiral cta with 3-d reconstruction is not available, the patient should be referred to a facility with these capabilities.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.¿ 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.¿ repositioning the stent graft distally after partial or complete deployment of the covered proximal stent may result in damage to the stent graft and/or vessel injury.¿ inaccurate placement and/or incomplete sealing of the zenith flex aaa endovascular graft within the vessel may result in increased risk of endoleak, migration or inadvertent occlusion of the renal or internal iliac arteries.Renal artery patency must be maintained to prevent/reduce the risk of renal failure and subsequent complications.¿ 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 flex aaa 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.5 adverse events: 5.2 potential adverse events: ¿ aneurysm enlargement.¿ 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 9 how supplied: ¿ the product is sterile if the package is unopened or undamaged.Inspect the device and packaging to verify that no damage has occurred as a result of shipping.Do not use this device if damage has occurred or if the sterilization barrier has been damaged or broken.If damage has occurred, do not use the product and return to cook.¿ store in a cool, dry place.10 clinical use information: 10.2 inspection prior to use: inspect the device and packaging to verify that no damage has occurred as a result of shipping.Do not use this device if damage has occurred or if the sterilization barrier has been damaged or broken.If damage has occurred, do not use the product, and return to cook.Prior to use, verify correct devices (quantity and size) have been supplied for the patient by matching the device to the order prescribed by the physician for that particular patient.11 directions for use: anatomical requirements: ¿ iliofemoral access vessel size and morphology (minimal thrombus, calcium and/or tortuosity) should be compatible with vascular access techniques and accessories.Arterial conduit techniques may be required.After review of the ifu, cook has concluded the device labeling contains appropriate warnings, precautions and instructions to the user related to the reported failure.Evidence provided by the complaint facility, device history record, complaint history, manufacturing documents, suggests that the device was manufactured to specification.There is no evidence of nonconforming devices in house or in the field.Based on the information provided, inspection of returned product and the results of the investigation, a definitive cause could not be established.Possible causes include the patient¿s anatomy or medical procedure may have contributed to this event.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 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 ILIAC LEG
• 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: 13446504
• MDR Text Key: 285039212
• Report Number: 1820334-2022-00160
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002484525
• UDI-Public: (01)10827002484525(17)230813(10)14148590
• Combination Product (y/n): N
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2022

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: 08/13/2023
• Device Model Number: G48452
• Device Catalogue Number: TFLE-12-107-ZT
• Device Lot Number: 14148590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/20/2022
• Initial Date FDA Received: 02/03/2022
• Supplement Dates Manufacturer Received: 02/07/2022; 05/18/2022
• Supplement Dates FDA Received: 02/22/2022; 06/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2021
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 62 KG