MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS DCS; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
|
Back to Search Results |
|
Model Number D-EVPROP2329US |
Device Problem
Detachment of Device or Device Component (2907)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/19/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Product analysis: upon receipt at medtronic's quality laboratory, the handle and capsule of the delivery catheter system (dcs) were intact.The device was received with the capsule partially opened.The deployment knob was able 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, inner member shaft and spindle hub were also intact.The actuator components were loose and separated during the retraction of the capsule.One tab of the actuator component was observed to be hinged inward and another tab was observed to have a hairline fracture at the point where the tab protrudes from the male actuator component.The device was returned with the end cap/screw gear snap fit connected.Conclusion: the investigation is in progress.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Medtronic received information that prior to the implant of this transcatheter bioprosthetic valve, the handle of the delivery catheter system (dcs) was disengaged at the start of the loading process, however was not completely separated.The dcs was replaced.No adverse patient effects were reported.
|
|
Manufacturer Narrative
|
Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.The delivery catheter system (dcs) was returned to medtronic for analysis and the actuator components were loose and separated during the retraction of the capsule, confirming the reported event.Tab 3 was observed to be hinged inward and tab 4 of the actuator component was observed to have a hairline fracture at the point where the tab protrudes from the male actuator component.Actuator separation is typically associated with broken or damaged snap fit tabs, either one tab or both, which hold the handle together.Updated section h.6 codes 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.
|
|
Manufacturer Narrative
|
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.
|
|
Search Alerts/Recalls
|
|
|