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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM REGENT HEART VALVE W/FLEX CUFF; HEART-VALVE, MECHANICAL
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ST. JUDE MEDICAL PUERTO RICO, INC. SJM REGENT HEART VALVE W/FLEX CUFF; HEART-VALVE, MECHANICAL Back to Search Results
Model Number 29AGFN-756
Device Problems Fracture (1260); Off-Label Use (1494); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/05/2020
Event Type  malfunction  
Manufacturer Narrative
Further information regarding this event has been requested.If returned, investigation results will be provided in a subsequent submission.
 
Event Description
On (b)(6) 2020 a regent valve was selected for a procedure.While the physician lowering the mechanical heart valve the two leaflets disengaged from the ring.The leaflet dislodged and fractured into multiple pieces while parachuting the valve.The leaflet was recovered from the patient.The procedure was successfully completed by using a different valve.There was a delay in the procedure.The patient remained hemodynamically stable through out the procedure and post procedure.There was no patient impact.
 
Manufacturer Narrative
The dislodged leaflet was confirmed.The leaflet was returned intact, with no other anomalies noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.While the root cause of the leaflet dislodgement could not be conclusively determined; however, the damage may have been caused by some external force applied to the valve which overstressed the carbon material.Furthermore, information from the field indicated that the holder was not attached to the valve at the time of parachuting it into place.Please note, per the instructions for use (ifu), artmt600080902 rev.B, "do not use instruments other than the valve holder handle to align and seat the valve, and exercise extreme care to avoid putting stress on the valve orifice or leaflets." step 5 states "parachute the valve into place," at which point step 6 indicates "cut the two retention sutures from the holder/rotator, and gently withdraw the holder/rotator from the valve." furthermore, information from the field indicated the physician believed the dislodged leaflet may have been the result of over-sizing.Per the warnings section of the ifu, "proper valve size selection is crucial.Do not oversize the valve.If the native annulus measurement falls between two sjm regent¿ mechanical heart valve sizes, use the smaller size sjm regent¿ mechanical heart valve.".
 
Manufacturer Narrative
The dislodged leaflet was confirmed.The leaflet was returned intact, with no other anomalies noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.While the root cause of the leaflet dislodgement could not be conclusively determined; however, the damage may have been caused by some external force applied to the valve which overstressed the carbon material.Furthermore, information from the field indicated that the holder was not attached to the valve at the time of parachuting it into place.
 
Event Description
On (b)(6) 2020 a 29mm regent valve was selected for a procedure.When the valve being lowered to be implanted, the two leaflets disengaged from the ring.The leaflet was recovered from the patient.The physician did not try to reinsert the dislodged leaflet.The valve was not on the holder when the leaflet dislodged.The procedure was successfully completed by using a different valve.There was a delay in the procedure.The patient remained hemodynamically stable through out the procedure and post procedure.There was no patient impact.The physician indicated that the event was due to over-sizing the device.
 
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Brand Name
SJM REGENT HEART VALVE W/FLEX CUFF
Type of Device
HEART-VALVE, MECHANICAL
Manufacturer (Section D)
ST. JUDE MEDICAL PUERTO RICO, INC.
p.o. box 998
lot 20 b st.
caguas, puerto rico 00725
MDR Report Key10251642
MDR Text Key198385865
Report Number2648612-2020-00067
Device Sequence Number1
Product Code LWQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Remedial Action Replace
Type of Report Initial,Followup,Followup
Report Date 09/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number29AGFN-756
Device Lot Number7372654
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2020
Was the Report Sent to FDA? No
Date Manufacturer Received09/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age22 YR
Patient Weight69
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