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

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/18/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a study patient in a clinical study experienced a type 1b endoleak on the right zenith flex with spiral-z technology aaa endovascular graft iliac leg.On (b)(6) 2017 (160 days pre-procedure), pre-procedure imaging revealed a stable type iv thoracoabdominal aortic aneurysm with mild iliac angulation.The location of start of aneurysm was unknown.The maximum aneurysm diameter was 85.0 mm.All branch vessels (celiac, sma, right and left renal) were patent, and there were no renal infarcts.During the index procedure on (b)(6) 2017, the patient received 4 cook devices and 3 competitor devices, including two custom made fenestrated branched devices, two iliac leg devices, two renal stents, and a superior mesenteric artery stent.There were no reported difficulties deploying the devices.Post-procedure imaging revealed no evidence of device integrity issues.However, a type iii endoleak at the junction of thoracic/abdominal/sma/right renal stent was identified.Imaging was completed on (b)(6) 2017, and the patient was diagnosed with a type 1b endoleak on the right zenith flex with spiral-z technology aaa endovascular graft iliac leg.The type iii endoleak at the junction of the of thoracic/abdominal/sma/right renal persisted.The site indicated that event was thought to be related to the study device and noted, ¿too short overlap with the previous tevar.¿ the event was not thought to be related to the study index procedure.On (b)(6) 2017 (14 days post-procedure), the patient was discharged from the hospital.On (b)(6) 2017 (26 days post-procedure), a balloon angioplasty was performed to treat the type 1b endoleak and the type iii endoleak.On (b)(6) 2017 (49 days post-procedure), the patient underwent a secondary intervention to treat the type i distal endoleak at the right iliac leg graft and type iii endoleak at the junction of thoracic/abdominal/sma/right renal stent.Treatment included balloon angioplasty, additional sma stent placement, right renal stent placement, and placement of a cook zenith alpha thoracic endovascular graft proximal component.The intervention was considered successful.On (b)(6) 2017 (89 days post-procedure), the 30-day post-procedure follow-up computed tomography (ct) scan revealed the maximum aneurysm diameter was 63.0 mm, and the devices were patent.There were no endoleaks, separation of components, evidence of migration or device integrity issues.On (b)(6) 2018 (268 days post-procedure), the patient was diagnosed with a false aneurysm between the aorta and left ventricle which led to cardiac failure.The event was treated with a diagnostic procedure and medication.The event was thought to not be related to the study device or the study index procedure.On (b)(6) 2018 (275 days post-procedure), the patient died.The cause of death was determined to be cardiac failure.The site noted,¿false aneurysm between aorta and left ventricle led to cardiac failure then death.¿.
Additional Manufacturer Narrative
Initial reporter: mobile: (b)(6).(b)(4).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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation it was reported that a study patient in a clinical study experienced a type 1b endoleak on the right zenith flex with spiral-z technology aaa endovascular graft iliac leg.On 02feb2017 (160 days pre-procedure), pre-procedure imaging revealed a stable type iv thoracoabdominal aortic aneurysm with mild iliac angulation.The location of start of aneurysm was unknown.The maximum aneurysm diameter was 85.0 mm.All branch vessels (celiac, sma, right and left renal) were patent, and there were no renal infarcts.During the index procedure on (b)(6) 2017, the patient received 4 cook devices and 3 competitor devices, including two custom made fenestrated branched devices, two iliac leg devices, two renal stents, and a superior mesenteric artery stent.There were no reported difficulties deploying the devices.Post-procedure imaging revealed no evidence of device integrity issues.However, a type iii endoleak at the junction of thoracic/abdominal/sma/right renal stent was identified.Imaging was completed on (b)(6)2017, and the patient was diagnosed with a type 1b endoleak on the right zenith flex with spiral-z technology aaa endovascular graft iliac leg.The type iii endoleak at the junction of the of thoracic/abdominal/sma/right renal persisted.The site indicated that event was thought to be related to the study device and noted, ¿too short overlap with the previous tevar.¿ the event was not thought to be related to the study index procedure.On (b)(6) 2017 (14 days post-procedure), the patient was discharged from the hospital.On 07aug2017 (26 days post-procedure), a balloon angioplasty was performed to treat the type 1b endoleak and the type iii endoleak.On 30aug2017 (49 days post-procedure), the patient underwent a secondary intervention to treat the type i distal endoleak at the right iliac leg graft and type iii endoleak at the junction of thoracic/abdominal/sma/right renal stent.Treatment included balloon angioplasty, additional sma stent placement, right renal stent placement, and placement of a cook zenith alpha thoracic endovascular graft proximal component.The intervention was considered successful.On 09oct2017 (89 days post-procedure), the 30-day post-procedure follow-up computed tomography (ct) scan revealed the maximum aneurysm diameter was 63.0 mm, and the devices were patent.There were no endoleaks, separation of components, evidence of migration or device integrity issues.On 06apr2018 (268 days post-procedure), the patient was diagnosed with a false aneurysm between the aorta and left ventricle which led to cardiac failure.The event was treated with a diagnostic procedure and medication.The event was thought to not be related to the study device or the study index procedure.On 13apr2018 (275 days post-procedure), the patient died.The cause of death was determined to be cardiac failure.The site noted,¿ false aneurysm between aorta and left ventricle led to cardiac failure then death.¿ reviews of documentation including the complaint history, drawing, device history record (dhr), quality control, specifications, manufacturing instructions (mi), and instructions for use (ifu), were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.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 dhrs for the reported complaint device lot and the related subassembly lots revealed one non-conformance.The non-conformance was properly identified, dispositioned, and sent to quality control for inspection.Cook has determined the non-conformance was not related to this failure mode.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The product ifu, t_zaaasz_rev3 ¿zenith spiral-z aaa iliac leg with the z-trak introduction system,¿ provides the following information to the user related to the reported failure mode: ¿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 enlarging aneurysms, 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 ¿ zenith spiral-z 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.¿ pre-existing regions of stenosis/narrowing (less than approximately 20 mm id in the aorta or 7 to 8 mm id in the iliacs) have been shown to increase the risk of a thromboembolic event (e.G., graft limb occlusion).The potential for this increased risk in these patients may preclude placement of an endovascular graft.Dilatation of these regions with a noncompliant balloon and/or stent placement may be necessary to help assure maintained graft patency and to reduce the risk of a thromboembolic event.Additionally, the completion angiogram (with stiff wire guides removed) should be reviewed carefully to determine if further treatment in these regions is necessary.(e.G., adjunctive ballooning or stenting ).Failure to remove the stiff wire guide prior to the angiogram could mask any limb kinking or narrowing that might occur when the wire guide is removed.4.3 pre-procedure measurement techniques and imaging lengths ¿ 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.¿ after endovascular graft placement, patients should be regularly monitored for perigraft flow, aneurysm growth or changes in the structure or position of the endovascular graft.At a minimum, annual imaging is required, including: 1) abdominal radiographs to examine device integrity (separation between components or stent fracture) and 2) contrast and non-contrast ct to examine aneurysm changes, perigraft flow, patency, tortuosity, and progressive disease.If renal complications or other factors precluded the use of image contrast media, abdominal radiographs and duplex ultrasound may provide similar information.4.4 device selection ¿ strict adherence to the zenith spiral-z aaa iliac leg ifu sizing guide is strongly recommended when selecting the appropriate device size.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 spiral-z aaa iliac leg and assure accurate apposition to the vessel wall.¿ inaccurate placement and/or incomplete sealing of the zenith spiral-z aaa iliac leg within the vessel may result in increased risk of endoleak, migration or inadvertent occlusion of the internal iliac arteries.5.2 potential adverse events adverse events that may occur and/or require intervention include, but are not limited to: ¿ aneurysm enlargement ¿ endoleak ¿ endoprosthesis: improper component placement, incomplete component deployment; component migration; component separation from another graft component; suture break; occlusion; infection; stent fracture; graft material wear; dilatation; erosion; puncture; perigraft flow; and corrosion 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) should receive enhanced follow-up.Specific follow-up guidelines are described in section 12, imaging guidelines and postoperative follow-up.11 directions for use 11.1.7 molding balloon insertion 5.Expand the molding balloon with diluted contrast media (as directed by the manufacturer) in the area of the most proximal covered stent and the infrarenal neck, starting proximally and working in the distal direction.6.Withdraw the molding balloon to the ipsilateral limb overlap region and expand.7.Withdraw the molding balloon to the ipsilateral distal fixation site and expand.8.Deflate and remove molding balloon.Transfer molding balloon onto the contralateral wire guide and into the contralateral iliac leg introduction system.Advance molding balloon to the contralateral limb overlap and expand.9.Withdraw the molding balloon to the contralateral iliac leg/vessel distal fixation site and expand.Final angiogram 2.Confirm there are no endoleaks or kinks and verify position of proximal gold radiopaque markers.Remove the sheaths, wires and catheters.Note: if endoleaks or other problems are observed, refer to the suggested instructions for use for the zenith aaa endovascular graft ancillary components.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) should receive additional follow-up.¿ based on the available information, no device return, and the results of the investigation, a definitive conclusion could not be established.Per the ifu, endoleak is a known inherent risk of the device.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.

• Brand Name: ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
• 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: 14935895
• Report Number: 1820334-2022-01160
• Device Sequence Number: 20291546
• Product Code: MIH
• UDI-Device Identifier: 10827002552453
• UDI-Public: (01)10827002552453(17)200503(10)7859138
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/03/2020
• Device Model Number: N/A
• Device Catalogue Number: ZSLE-24-56-ZT
• Device Lot Number: 7859138
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2022
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2017
• 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: COOK AAA-BRANCH-GRAFT, LOT AC993705; COOK ILIAC LEG GRAFT, ZSLE-24-74-ZT, LOT 7889101; COOK THORACO-ABDOMINAL-SIDE-BRANCH, LOT AC993706; RENAL STENT: FLUENCY, FVL10100; RENAL STENT: FLUENCY, FVL7060; SMA STENT: FLUENCY 10188, FVL10080
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 59 KG