Model Number EVOLUTPRO-29 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Arrhythmia (1721); Non specific EKG/ECG Changes (1817)
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Event Date 10/24/2018 |
Event Type
Injury
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Manufacturer Narrative
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Product analysis: the product remains implanted; therefore, no product analysis can be performed conclusion: conduction disturbances are known potential adverse effects associated with any cardiac or thoracic procedure (open or c atheter-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 manuf acturing issue.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 at an unknown time following the implant of this transcatheter bioprosthetic valve, nonsustained ventricular tachycardia, first degree atrio-ventricular (av) block and complete left bundle branch block (lbbb) occurred.Subsequently, a permanent pacemaker was implanted 4 months and 25 days following the implant of the valve.No additional adverse patient effects were reported. .
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Manufacturer Narrative
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Additional information reported that following the implant of this valve, left bundle branch block (lbbb) was reported on the day of the valve implant procedure.No additional adverse patient effects were reported. if information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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