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COOK INC ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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| Model Number N/A |
| Device Problems
Complete Blockage (1094); Obstruction of Flow (2423)
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| Patient Problems
Ischemia (1942); Thrombosis/Thrombus (4440)
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| Event Date 03/10/2020 |
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Event Type
malfunction
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Manufacturer Narrative
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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.
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Event Description
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It was reported that the zenith flex with spiral-z technology aaa endovascular graft iliac leg placed in the right common iliac artery was found to be occluded 4 years after placement in a male patient.During the index endovascular abdominal aortic repair (evar) procedure on (b)(6) 2016, the following devices were implanted into the patient: cook devices: rpn: pbranch-32-22-a, lot: ac944073x.Rpn: unibody-24-81, lot: ac944012.Rpn: zsle-13-74-zt, lot: 6556367 (right common iliac).Rpn: zsle-16-74-zt, lot: 6751596 (left common iliac).Non-cook devices: sma covered stent 7 mm x 22 mm.Right renal covered stent 6 mm x 22 mm.Left renal covered stent 6 mm x 22 mm.The devices were deployed successfully, and a molding balloon was used without complication.The completion angiogram demonstrated that the devices were patent with no device integrity issues or endoleaks.Core lab assessment of the completion angiogram occurred with the site assessment.On (b)(6) 2016 (28 days post-procedure), the follow up ct was completed and revealed that the maximum aneurysm diameter was 53 mm.The devices were patent with no separation of components, evidence of migration, device integrity issues or endoleaks.Core lab analysis revealed the maximum aneurysm diameter to be 54.40 mm.The devices were patent and there was no separation of components, evidence of migration, device integrity issues or endoleaks.On (b)(6) 2016 (180 days post-procedure), the 6-month follow up ct was completed and revealed the maximum aneurysm diameter to be 45 mm.The devices were patent with no separation of components, evidence of migration, device integrity issues or endoleaks.Core lab analysis revealed the maximum aneurysm diameter was 46.1 mm.The devices were patent and there was no separation of components, evidence of migration, device integrity issues or endoleaks.On (b)(6) 2017 (379 days post-procedure), the 12-month follow-up ct was completed and revealed the maximum aneurysm diameter was 40.0 mm.The devices were patent with no separation of components, evidence of migration, device integrity issues or endoleaks.Core lab analysis revealed the maximum aneurysm diameter was 42.6 mm.The devices were patent and there was no separation of components, evidence of migration, device integrity issues or endoleaks.On (b)(6) 2018 (731 days post-procedure), the 2-year follow-up ct was completed and revealed the maximum aneurysm diameter was 39.5 mm.The devices were patent with no separation of components, evidence of migration, device integrity issues or endoleaks.Core lab analysis revealed the maximum aneurysm diameter was 38.1 mm.The devices were patent and there was no separation of components, evidence of migration, device integrity issues or endoleaks.On (b)(6) 2019 (1133 days post-procedure), the 3-year follow-up ct was completed and revealed the maximum aneurysm diameter was 38.7 mm.The devices were patent with no separation of components, evidence of migration, device integrity issues or endoleaks.Core lab analysis revealed the maximum aneurysm diameter was 36.3 mm.The devices were patent and there was no separation of components, evidence of migration, device integrity issues or endoleaks.On (b)(6) 2020 (1453 days post-procedure), the 4-year follow-up ct was completed and revealed the maximum aneurysm diameter was 38.4 mm.There was no separation of components, evidence of migration, device integrity issues or endoleaks.The right iliac leg graft was not patent.Core lab analysis revealed the maximum aneurysm diameter was 37.9 mm.There was no separation of components, evidence of migration, device integrity issues or endoleaks.The right iliac leg graft was not patent.The patient was diagnosed with right common iliac artery stent-graft occlusion, in which there was no treatment.It was noted that, ¿patient denied ischemic symptoms, right external iliac artery is patent and opacified presumable via pelvic collaterals from the internal iliac artery and abdominal wall collateral from the right inferior epigastric artery and right deep circumflex iliac artery.No treatment was recommended at the moment.¿ the site indicated that the event was unlikely to be related to the study product and not related to the study procedure.The site answered ¿yes¿ to the question did the device malfunction or deteriorate in characteristics or performance and ¿no¿ to the question could this event have led to death or serious deterioration in health had suitable intervention not occurred.¿ on (b)(6) 2021 (1802 days post-procedure), the 5-year follow-up ct was completed and revealed the maximum aneurysm diameter was 38.4 mm.There was no separation of components, evidence of migration, device integrity issues or endoleaks.The right iliac leg graft was not patent.Core lab analysis revealed the maximum aneurysm diameter was 37.6 mm.There was no separation of components, evidence of migration, device integrity issues or endoleaks.The right iliac leg graft was not patent.The site noted that, "on (b)(6) 2021, the patient has right leg claudication symptoms, but no rest pain symptoms and no tissue loss.Vascular department recommended a fem-fem bypass procedure, but the patient was to continue to conservative measures.¿ the patient completed the final study visit on (b)(6) 2021.No harm to the patient has been reported at this time.Additional information regarding patient outcome has been requested but is currently unavailable.
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Event Description
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In additional information received on 24jul2023, it was reported that no other interventions have taken place.The patient has refused to have a fem-fem bypass and opted to have cta (computed tomography angiography) and duplex ultrasound follow-ups at an outside hospital.The patient will also continue walking.No medications are mentioned in the medical record.
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Manufacturer Narrative
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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.
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Event Description
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No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown, unchanged or unavailable.Correction: h6 - annex a.Investigation ¿ evaluation: ut southwestern informed cook on 30jun2023 of an incident involving a zenith flex with spiral-z technology aaa endovascular graft iliac leg (zsle-13-74-zt) lot 6556367.The male patient was part of the 14-09 zenith p-branch pivotal study.The patient had an initial evar (endovascular aneurysm repair) procedure completed on 18mar2016 in which the following devices were placed: pbranch-32-22-a (lot ac944073x), unibody-24-81 (lot ac944012), zsle-13-74-zt (lot 6556367) placed in the right common iliac and a zsle-16-74-zt (lot 6751596) placed in the left common iliac artery.In addition to the cook devices the patient also received the following non-cook devices: sma covered stent (7mm x 22mm), right renal covered stent (6mm x 22mm) and a left renal covered stent (6mm x 22mm).At the time of enrollment pre-operative imaging was conducted by the site and noted a stable juxtarenal aortic aneurysm.The proximal sealing zone showed no calcification, occlusive disease or thrombus.There was mild calcification and tortuosity of the bilateral iliacs.There was mild calcification of the external iliac arteries.The right external iliac artery had mild occlusive disease.The patient continued regular follow-ups with no issues until (b)(6) 2020.A four-year follow-up was completed and revealed the right iliac leg graft was not patent.The patient was diagnosed with right common iliac artery stent-graft occlusion (no flow of blood).There was no treatment.It was noted, ¿patient denied ischemic symptoms, right external iliac artery is patent and opacified presumable via pelvic collaterals from the internal iliac artery and abdominal wall collateral from the right inferior epigastric artery and right deep circumflex iliac artery.No treatment was recommended at the moment.¿ on (b)(6) 2021 (1802 days post-procedure), the 5-year follow-up ct was completed which revealed the maximum aneurysm diameter was 38.4 mm.There was no separation of components, evidence of migration, device integrity issues, or endoleak.The right iliac leg graft was not patent.Core lab analysis revealed the maximum aneurysm diameter was 37.6 mm.There was no separation of components, evidence of migration, device integrity issues, or endoleaks.The right iliac leg graft was not patent.The site noted, ¿on (b)(6) 2021, the patient has right leg claudication symptoms, but no rest pain symptoms and no tissue loss.Vascular department recommended a fem-fem bypass procedure, but the patient was to continue to conservative measures.¿ it was clarified that in this event "conservative measures" means: "the patient refused to have a fem-fem bypass and just wanted to have cta and duplex us follow-up along with that the patient will continue walking, no medications are mentioned in the medical record." there have been no additional interventions that the site is aware of.This patient was having follow-up at an outside hospital.Reviews of the documentation, including the complaint history, device history record, drawing, instruction for use (ifu), manufacturing instructions, quality control procedures and specifications of the device, were conducted during the investigation.The complaint device was not returned for evaluation; therefore, no physical examination could be performed.However, imaging was provided by the facility for expert review.Thrombosis of the right zsle-13-74-zt between the 36 and 48 month follow up was confirmed.Thrombosis risk was increased by a diminutive and stenotic right eia and mean distal aortic lumen diameter less than 20mm.Despite these challenges, the leg was normal for over 36 months.Temporary discontinuation of anticoagulation or antiplatelet therapy is a possible cause of thrombosis.During the same interval that the zsle thrombosed, a right renal calculus was removed.Its removal would have required lithotripsy and or ureteroscopy.Anticoagulation or antiplatelet therapy would have been temporarily discontinued for lithotripsy.Temporary discontinuation would likely have occurred for ureteroscopy because the endograft had been in over 36 months.Additionally, 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 6556367 found no nonconformances that could have contributed to the reported failure mode.It should be noted that there are no other complaints associated with the final product lot number.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: 4.1 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 aneurysms, 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 sire 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.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 14 french to 16 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.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.Follow-up imaging should be carefully reviewed for narrowing within the leg graft.Patients with a graft leg lumen of less than approximately 5 mm id may be at increased risk of a thromboembolic event (e.G., graft limb occlusion).Reintervention (e.G., noncompliant ballooning or stenting in these regions) should be considered to help assure maintained graft patency and to reduce the risk of a thromboembolic event.Patients with poor outflow or a hypercoagulable state (e.G, cancer) may be at an increased risk of a thromboembolic event.The zenith spiral-z aaa iliac leg 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.Inability to maintain patency of at least one internal iliac artery or occlusion of an indispensable inferior mesenteric artery may increase the risk of pelvic/bowel ischemia 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.4.5 implant procedure.Inaccurate placement and/or incomplete sealing of the zenith spiral-z endovascular aaa iliac leg within the vessel may result in increased risk of endoleak, migration or inadvertent occlusion of the internal iliac arteries excessive overlap 10mm above the main body bifurcation may increase the risk of limb thrombosis.5.2 potential adverse events adverse events that may occur and/or require intervention include, but are not limited to: aortic damage, including perforation, dissection, bleeding, rupture and death arterial or venous thrombosis and/or pseudoaneurysm endoprosthesis: improper component placement; incomplete component deployment; component migration; component separation from another graft component/ suture break; occlusion; infection; stent fracture; graft material wear; dilation; erosion; puncture; pergraft flow; and corrosion graft or native vessel occlusion renal complications and subsequent attendant problems (e.G., dehiscence, infection) vessel damage.7.1 individualization of treatment the risks and benefits should be carefully considered for each patient before use of the zenith spiral-z aaa iliac leg.Additional considerations for patient selection include, but are not limited to: patient¿s age and life expectancy.Co-morbidities (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 the risk of aneurysm rupture compared to the risk of treatment with zenith spiral-z aaa iliac leg.Patient¿s ability to tolerate general, regional or local anesthesia iliofemoral access vessel size and morphology (minimal thrombus, calcification and/or tortuosity) should be compatible with vascular access techniques and accessories of the delivery profile of a 14 french to 16 french vascular introducer sheath zenith spiral-z iliac artery distal fixation site greater than 10 mm in length and 7.5-20mm 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.In addition to the risks and benefits of an endovascular repair, the physician should assess the patient¿s commitment and compliance to postoperative follow-up as necessary to ensure continuing safe and effective results.Listed below are additional topics to discuss with the patient as to expectations after an endovascular repair: 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 enhanced follow-up.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 a 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 life-long 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.Evidence provided by the complaint facility, device failure analysis, dhr, complaint history, and manufacturing documents suggests that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.Based on the information provided, expert review of imaging provided, and the results of our investigation, it was concluded that patient condition/anatomy likely contributed to the thrombus.The image reviewer noted thrombosis risk was increased by a diminutive and stenotic right eia and mean distal aortic lumen diameter less than 20mm.Despite these challenges, the leg was normal for over 36 months.In addition to this core lab analysis also noted there was mild calcification and mild occlusive disease of the right external iliac artery.Although medications were not confirmed the image reviewer also stated the following ¿temporary discontinuation of anticoagulation or antiplatelet therapy is a possible cause of thrombosis.During the same interval that the zsle thrombosed, a right renal calculus was removed.Its removal would have required lithotripsy and or ureteroscopy.Anticoagulation or antiplatelet therapy would have been temporarily discontinued for lithotripsy.Temporary discontinuation would likely have occurred for ureteroscopy because the endograft had been in over 36 months.¿ thrombus is a known inherent risk of device use per the 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.
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