MEDTRONIC HEART VALVES DIVISION ENVEO PRO DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number ENVPRO-16 |
Device Problems
Difficult or Delayed Positioning (1157); Mechanical Problem (1384); Patient Device Interaction Problem (4001)
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Patient Problem
Vascular Dissection (3160)
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Event Date 01/14/2022 |
Event Type
Injury
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Event Description
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Medtronic received information that prior to the implant of this transcatheter bioprosthetic valve, a pre-implant dilatation was per formed with a 24 millimeter (mm) non-medtronic balloon.The patient had a calcified aortic valve with an annulus perimeter measuring 86.1 mm with an annular angulation of 63 degrees.The delivery catheter system (dcs) was inserted over a guidewire (meier).The valve implant began in the cusp overlap technique (cot) projection where the valve was deployed to 80%.The valve was at a high depth on the left coronary cusp (lcc).A second deployment attempt was made in the left anterior oblique (lao) projection.The valve remained high on the lcc.The valve was repositioned six times at different heights at the non-coronary cusp (ncc), all ending with the same result until the shaft of the dcs close to the capsule became compressed.During the third attempt, it was reported that the struts of the inflow portion of the valve could not be fully recaptured over the nose cone.The valve was recaptured a total of five times and was eventually withdrawn from the patient.A decision was made to implant a 29 mm non-medtronic valve.During the preparation of the non-medtronic valve, a dissection was observed in the ascending aorta and the patient was transferred to open heart surgery.Per the physician, it was believed that the dissection occurred during the third deployment attempt, as the struts of the inflow portion of the valve were not able to be completely recaptured and it was not possible to move the dcs coaxial into the left ventricle.During the open heart surgery, a biological valve was implanted and the dissection was sutured.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Product analysis: upon receipt at medtronic¿s quality laboratory, the valve was received loaded in the capsule of the delivery catheter system (dcs).On attempted retraction of the capsule via the rotation of the deployment knob, the valve deployed as expected.The handle appeared intact.The device was received with the capsule partially opened and the inflow portion of the valve was visible.The deployment knob appeared to retract and advance the capsule.The trigger moved to fully advanced and retracted positions and locked in place when released.The tip-retrieval mechanism appeared intact.The device was returned with the end cap / screw gear snap fit connected.Delamination is observed along the length of the capsule.There was a buckle observed in the capsule nitinol reinforcing frame near the proximal end of the capsule.The inner member shaft and spindle hub appeared intact with no evidence of damage.Damage was noted along the outflow support.There was damage observed on the threading of the screw gear.Upon deployment of the valve, damage was evident along proximal portion of the capsule.The reported event for positioning difficulties and difficult could be confirmed in the analysis.The reported event for shaft compression related to buckle on the capsule could be confirmed in the analysis.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Conclusion: delamination was observed on the capsule, which typically occurs when the capsule is subjected to a bending force potentially after tracking through tortuous anatomy.There was a buckle observed in the capsule nitinol reinforcing frame near the proximal end of the capsule which can be justified by the multiple, off label, recaptures.There was also damage observed on the threading of the screw gear.This damage indicated high forces in the system.High forces in the handle may cause the threading of the screw gear to become worn and damaged.Many sources may contribute to high forces in the system including load quality and packing density of the valve in the capsule, bends and kinks on the shaft, tortuous anatomy and guidewire and sheath selection.High forces are consistent with the capsule damage and the difficulty recapturing.Images were also received for review.The valve was correctly inserted and based on the description, the first valve attempts are following the best practices except for the pig-tail position.The valve was recaptured too many times according to the instructions for use (ifu), and after the third recapture the system should have been withdrawn from the patient.The images received and the computed tomography (ct) scan do not show any potential cause for the dissection except for the multiple valve repositioning.The capsule damage can be justified by the multiple, off label, recaptures.Recapturing is a feature of the evolut system that allows for additional attempts at accurately positioning the valve.Various factors can affect valve positioning including patient anatomy or physician technique.In this case, it was reported that the patient presented with a calcified aortic valve with an annulus perimeter measuring 86.1 millimeters (mm) and an annular angulation of 63 degrees.This indicated that the probable cause of the positioning difficulties was patient anatomy.Per the ifu, deployment of the bioprosthesis can be attempted 3 times.If the bioprosthesis is recaptured a third time, it must be removed from the patient.It was reported that the valve was recaptured five times which indicated use error.Vascular complications, such as dissection, are known potential adverse patient effects per the evolut system ifu, and are typically related to patient factors (anatomy, comorbidities, etc.), and/or procedural effects (sheath used, user technique, puncture cut location, etc.).A device history record (dhr) review was performed on the dcs and there were no correlations / issues identified regarding manufacturing.The device was manufactured per approved and released manufacturing processes and the device met all applicable manufacturing specifications prior to release for distribution.The dhr review did not show any findings related to this event.There was no information to suggest a device quality deficiency that may have caused or contributed to this event.Updated h6.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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