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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION EVOLUT PRO TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

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MEDTRONIC HEART VALVES DIVISION EVOLUT PRO TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED Back to Search Results
Model Number EVOLUTPRO-29
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arrhythmia (1721); Non specific EKG/ECG Changes (1817)
Event Date 10/24/2018
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
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. .
 
Manufacturer Narrative
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.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
EVOLUT PRO TRANSCATHETER AORTIC VALVE
Type of Device
AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
Manufacturer (Section D)
MEDTRONIC HEART VALVES DIVISION
1851 e deere ave
santa ana CA 92705
MDR Report Key8202859
MDR Text Key131612964
Report Number2025587-2018-03566
Device Sequence Number1
Product Code NPT
Combination Product (y/n)N
PMA/PMN Number
P130021
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 02/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/09/2018
Device Model NumberEVOLUTPRO-29
Device Catalogue NumberEVOLUTPRO-29
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/05/2018
Initial Date FDA Received12/28/2018
Supplement Dates Manufacturer Received01/25/2019
02/05/2019
Supplement Dates FDA Received01/29/2019
02/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age79 YR
Patient Weight78
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