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MEDTRONIC HEART VALVES DIVISION ENVEO PRO DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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| Model Number ENVPRO-14 |
| Device Problems
Break (1069); No Apparent Adverse Event (3189)
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| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 01/18/2022 |
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Event Type
malfunction
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Manufacturer Narrative
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Product analysis: the delivery catheter system (dcs) was not returned therefore no product analysis can be performed.Conclusion: without return of the products, 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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Event Description
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Medtronic received information that during the implant of this transcatheter bioprosthetic valve using this delivery catheter system (dcs), it was reported that the dcs had broke.Per the physician, a cracking sound was heard and afterward the handle did not work and the capsule would not go down.Per the physician, it was believed that the issue was due to the challenging anatomy on the way to the annulus which was tortuous and calcified.The dcs and valve were removed from the patient and a different (non-medtronic) valve was implanted.No adverse patient effects were reported.
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Manufacturer Narrative
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Product analysis: the delivery catheter system (dcs) was not returned therefore no product analysis can be performed.Conclusion: without return of the products, 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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Event Description
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Medtronic received information that during the implant of this transcatheter bioprosthetic valve using this delivery catheter system (dcs), it was reported that the dcs had broke.Per the physician, a cracking sound was heard and afterward the handle did not work and the capsule would not go down.Per the physician, it was believed that the issue was due to the challenging anatomy on the way to the annulus which was tortuous and calcified.The dcs and valve were removed from the patient and a different (non-medtronic) valve was implanted.No adverse patient effects were reported.
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Manufacturer Narrative
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Medtronic received additional information that changed the event description.It was reported that the portion of the delivery catheter system (dcs) that broke was the end cap.Per the physician, the separation was likely due to tortuosity and calcification in the femoral artery and aortic arch.There was no evidence to suggest the device caused or contributed to a death or serious injury.Product analysis: upon receipt at medtronic¿s quality laboratory, the valve was received loaded in the capsule of the delivery catheter system (dcs).The handle and tip-retrieval mechanism of the dcs were intact.The capsule was fully closed.The deployment knob and trigger did not retract or advance the capsule.Delamination was observed over the nitinol reinforcing frame along the proximal end of the capsule.The valve could not be removed from the dcs, therefore analysis on the valve could not be performed.The device was received with the end cap separated.The end cap was attempted to be reattached by the analysis technician.It was noted that upon rotation of the deployment knob it separated, and the capsule could not retract and advance either with the knob or the trigger.The dcs was returned with the end cap separated, therefore confirming the reported event.Updated codes: 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.
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Manufacturer Narrative
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Corrected data: h3.The device was evaluated and reported via supplemental device evaluation regulatory rep #: 2025587-2022-00485.However, the h3.Section was inadvertently omitted from that report.Updated data: g1.Manufacturer contact name and information h6.Eval code result and eval code conclusion conclusion: the device history record was reviewed and showed that this product, delivery catheter system (dcs), met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.End cap separation refers to an event where the end cap/screw gear snap fit fails and the capsule of the dcs cannot retract.The failure occurs when the system forces exceed the tensile strength of the joint.The force on the dcs is a cumulative effect that can be increased by many factors, including patient anatomy, access route, and load quality.In this case the cause of the potential end cap separation, per the physician, was likely due to patient anatomy (tortuosity and calcification in the femoral artery and aortic arch); however, this cannot be conclusively confirmed with the limited information available.There is no information to suggest a device quality deficiency that may have caused or contributed to this event.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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