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

Model Number	G48413
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 type 1a endoleak occurred on a zenith flex aaa endovascular graft bifurcated main body during an endovascular aneurysm repair (evar) procedure.The patient was on heparin.The device was reported to have been deployed per the instructions for use (ifu).Completion angiogram revealed a type 1a endoleak.In response, a coda balloon was re-inserted and inflated in the proximal seal zone.Following, an additional angiogram revealed that the endoleak had not been resolved, so it was decided that eight competitor endo-anchors would be placed circumferentially around/in the proximal seal stent.A final angiogram showed that the endoleak had then been resolved.The aneurysm was successfully excluded.No other adverse effects to the patient have been reported.
Additional Manufacturer Narrative
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
Additional information was received on 03sep2021.As there was no clear endoleak identified the ct scan, the patient will continue to be monitored with short interval follow-up imaging in three months.
Event or Problem Description
In additional information received 24aug2021, it was reported that there was no calcification, tortuosity, or thrombus present in the aortic neck.The length of the non-aneurysmal landing zone in the aortic neck was reported to be 2.5cm.Following the procedure, the one month computed tomography angiography (cta) showed no endoleak.A duplex ultrasound showed endoleak but no flow into the aneurysm sac.
Additional 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 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 patient and/or event details has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Investigation ¿ evaluation.Dr.(b)(6) at (b)(6) medical center informed cook of an incident involving a zenith flex aaa endovascular main body graft (tffb-26-96-zt).The female patient had pre-existing conditions of an abdominal aortic aneurysm and vascular disease.On (b)(6) 2021, during an endovascular aneurysm repair, the device was deployed according to ifu (instructions for use).During completion of an angiogram a type 1a endoleak was discovered.A coda balloon was inserted for a second time and inflated at the proximal seal zone.Another angiogram was done and showed no resolve of the endoleak.At this point it was decided to place aptus endoanchors in the proximal seal stent of the main body.A total of eight endoanchors were placed circumferentially around the seal stent.An angiogram was completed and showed resolve of the endoleak.Additional information received from dr.(b)(6) stated that the length of non-aneurysmal landing zone was 2.5cm.The physician has stated there was no calcification, tortuosity, or thrombus present in the aortic neck.At the patient¿s one month follow-up a cta (computed tomography angiography) scan was completed and showed no endoleak.A duplex was performed and showed there was an endoleak present.The physician stated while there was an endoleak identified it was not filling into the aneurysm sack clearly.Therefore, it was decided to continue to monitor the endoleak with short interval follow-up imaging in three months.A review of the documentation including the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control and specifications of the device was conducted during the investigation.The complaint device was not returned for evaluation; therefore, no physical examinations could be conducted.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) for lot 14018440 found no related nonconformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with this lot number.As there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field the instructions for use (ifu) provides the following information related to the reported failure mode: 1 device description: 1.1 aortic main body and iliac leg components: the modules are fully stented to provide stability and the expansile force necessary to open the lumen of the graft during deployment.Additionally, the cook-z stents provide the necessary attachment and seal of the graft to the vessel wall.The bare suprarenal stent at the proximal end of the graft contains barbs that are placed at 3 mm increments for additional fixation of the device.To facilitate fluoroscopic visualization of the stent graft, gold radiopaque markers are positioned as follows: one on the lateral aspect of the most distal stent on the contralateral limb of the bifurcated section of the main body and four in a circumferential orientation within 2 mm of the most superior aspect of the graft material.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: 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.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.Diameters utilizing ct, diameter measurements should be determined from the outer wall to outer wall vessel diameter (not lumen measurement) to help with proper device sizing and device selection.The contrast-enhanced spiral ct scan must start 1 cm superior to the celiac axis and continue through the femoral heads at an axial thickness slice of 3 mm or less.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: appropriate procedural imaging is required to successfully position the zenith flex aaa endovascular graft and assure accurate apposition to the aortic wall.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.5.2 potential adverse events: adverse events that may occur and/or require intervention include, but are not limited to: 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.6.5 endoleak management: during the clinical study type i endoleaks were treated during the initial procedure by use of additional balloon seating or if unsuccessful, additional prostheses.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.8 patient counseling information: patients with specific clinical findings (e.G., endoleaks, enlarging aneurysms or changes in the structure or position of the endovascular graft) should receive enhanced follow-up.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.10.5 device sizing guidelines: the choice of diameter should be determined from the outer wall to outer wall vessel diameter and not the lumen diameter.Undersizing or oversizing may result in incomplete sealing or compromised flow.11 directions for use: anatomical requirements: proximal aortic neck lengths should be a minimum of 15 mm with a diameter measured outer wall to outer wall of 18 ¿ 32 mm.Pre-implant determinants verify from pre-implant planning that the correct device has been selected.Determinants include: 1.Femoral artery selection for introduction of the main body system (i.E., define respective contralateral and ipsilateral iliac arteries).2.Angulation of aortic neck, aneurysm, and iliac arteries.3.Quality of the aortic neck.4.Diameters of infrarenal aortic neck and distal iliac arteries.5.Distance from renal arteries to the aortic bifurcation.6.Length from the aortic bifurcation to the internal iliac arteries/attachment site(s).7.Aneurysm(s) extending into the iliac arteries may require special consideration in selecting a suitable graft/artery interface site.8.Consider the degree of vascular calcification.11.1.5 main body placement 4.Before insertion, position main body delivery system on patient¿s abdomen under fluoroscopy to determine the orientation of the contralateral limb radiopaque marker.The sidearm of the hemostatic valve may serve as an external reference to the contralateral limb radiopaque marker.5.Insert main body delivery system over the wire, into the femoral artery with attention to sidearm reference.Caution: maintain wire guide position during delivery system insertion.Caution: to avoid any twist in the endovascular graft, during any rotation of the delivery system, be careful to rotate all the components of the system together (from outer sheath to inner cannula).6.Advance delivery system until the four gold radiopaque markers (which are positioned 2 mm from the most proximal segment of the graft material) are just inferior to the most inferior renal orifice.7.Verify position of wire guide in the thoracic aorta.Ensure the graft system is oriented such that the contralateral limb is positioned above and anterior to the origin of the contralateral iliac.If the contralateral limb radiopaque marker is not properly aligned, rotate the entire system until it is correctly positioned halfway between a lateral and an anterior position on the contralateral side.A marker formation of a indicates an anterior position of the short (contralateral) limb.A marker formation of a indicates a posterior position of the short (contralateral) limb.A marker formation of a | indicates a lateral position of the short (contralateral) limb.Note: radiopaque cannula on each stent between the renal arteries and the contralateral limb align with the contralateral limb radiopaque marker.8.Repeat the angiogram to verify the four gold radiopaque markers are 2 mm or more below the most inferior renal orifice.Note: verify contralateral limb is at least 5 mm above the aortic bifurcation and in desired location for cannulation.Final angiogram 1.Position angiographic catheter just above the level of the renal arteries.Perform angiography to verify that the renal arteries are patent and that there are no endoleaks.Verify patency of internal iliac arteries.2.Confirm there are no endoleaks or kinks and verify position of proximal gold radiopaque markers.Remove the sheaths, wires, and catheters.12.4 ultrasound ultrasound imaging may be performed in place of contrast ct when patient factors preclude the use of image contrast media.Ultrasound may be paired with non-contrast ct.A complete aortic duplex is to be videotaped for maximum aneurysm diameter, endoleaks, stent patency and stenosis.Included on the videotape should be the following information as outlined below: transverse and longitudinal imaging should be obtained from the level of the proximal aorta demonstrating mesenteric and renal arteries to the iliac bifurcations to determine if endoleaks are present utilizing color flow and color power angiography (if accessible).Spectral analysis confirmation should be performed for any suspected endoleaks.Transverse and longitudinal imaging of the maximum aneurysm should be obtained.12.6 additional surveillance and treatment: additional surveillance and possible treatment is recommended for: aneurysms with type i endoleak.Based on the information provided, no returned product and the results of our investigation, a definitive cause for the event could not be established.Endoleak is a known inherent risk of the device per ifu.The appropriate personnel have been notified.Per the risk assessment no further action is required.We 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 FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
• 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: 12204911
• Report Number: 1820334-2021-01844
• Device Sequence Number: 17235842
• Product Code: MIH
• UDI-Device Identifier: 10827002484136
• UDI-Public: (01)10827002484136(17)230616(10)14018440
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/14/2021

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: 06/16/2023
• Device Model Number: G48413
• Device Catalogue Number: TFFB-26-96-ZT
• Device Lot Number: 14018440
• 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: 07/13/2021
• Supplement Date Received by Manufacturer: 08/24/2021; 09/03/2021; 11/18/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 09/02/2021; 09/15/2021; 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2021
• 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: APTUS ENDO-ANCHORS QTY. 8; COOK CODA BALLOON; UNKNOWN ILIAC LEG GRAFTS QTY. 2; APTUS ENDO-ANCHORS QTY. 8; COOK CODA BALLOON; UNKNOWN ILIAC LEG GRAFTS QTY. 2
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female