MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
|
Back to Search Results |
|
Model Number EVPROPLUS-26US |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Bradycardia (1751); Non specific EKG/ECG Changes (1817); Tachycardia (2095)
|
Event Date 11/18/2022 |
Event Type
Injury
|
Event Description
|
Medtronic received information that following the valve implant tachy/brady conduction disease was identified.This was reported as probably related to the valve and valve implant procedure.One day following the implant of this transcatheter bioprosthetic valve, electrocardiogram (ecg) showed left bundle branch block (lbbb).A two-week continuous heart monitor was utilized for diagnostics.Treatment was not reported.No patient symptoms reported.However, approximately three months and 16 days following the valve implant a permanent pacemaker was implanted.No additional adverse patient effects were reported.
|
|
Manufacturer Narrative
|
Product analysis: the device remains implanted, therefore no product analysis can be performed.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.Conduction disturbances are known potential adverse effects associated with any cardiac or thoracic procedure (open or catheter-based) and can be resolved with medical treatment or the implant of a permanent pacemaker (with the risk-benefit ratio in favor of implant of the percutaneous aortic valve).A conduction disturbance does not indicate a device malfunction or potential manufacturing issue.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
|
Updated data: b5 continuation of d10: product id l-evprop2329us; product type: 0195-heart valves; lot number: 0010917557 product id d-evprop2329us; product type: 0195-heart valves; lot number: 0010893752 h6.The codes present in section h6 correspond to multiple components/products that comprise this reported 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.
|
|
Event Description
|
Additional information received reported a change in the physician¿s assessment.Per the physician, the tachy/brady conduction disease was not related to the valve or the valve implant procedure.
|
|
Search Alerts/Recalls
|
|
|