Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL REGENT HEART VALVE WITH FLEX CUFF; HEART-VALVE, MECHANICAL
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ABBOTT MEDICAL REGENT HEART VALVE WITH FLEX CUFF; HEART-VALVE, MECHANICAL Back to Search Results
Catalog Number 19AGFN-756
Device Problems Fracture (1260); Incomplete Coaptation (2507); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/29/2024
Event Type  malfunction  
Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that on (b)(6) 2024, a 19mm regent aortic mechanical heart valve was chosen for implantation.Before implantation, a resection was performed which completely decalcified the leaflet.Using the sizing ring, the annulus was measured to be 19mm.When the suture was passed through the sewing cuff and knotted, it was noticed that the ring was fractured and a disc was stuck.The valve was removed.There had been resistance while rotating.Holder handle was fully inserted into the orifice at a 90 degree angle.All pieces of the fractured ring were removed from the anatomy.The physician decided to enlarge the aortic ring via the yang technique and implant a replacement 23mm regent aortic valve.There were no adverse patient consequences or clinically significant delay.The patient remained hemodynamically stable throughout the procedure.The patient remained on cardiopulmonary bypass throughout the procedure without intervention.There was a reported delay that resulted in no patient consequences.
 
Event Description
It was reported that on (b)(6) 2024, a 19mm regent aortic mechanical heart valve was chosen for implantation.Before implantation, a resection was performed which completely decalcified the leaflet.Using the sizing ring, the annulus was measured to be 19mm.When the suture was passed through the sewing cuff and knotted, it was noticed that the ring was fractured and a disc was stuck.The valve was removed.There had been resistance while rotating.Holder handle was fully inserted into the orifice at a 90 degree angle.All pieces of the fractured ring were removed from the anatomy.The physician decided to enlarge the aortic ring via the yang technique and implant a replacement 23mm regent aortic valve.There were no adverse patient consequences or clinically significant delay.The patient remained hemodynamically stable throughout the procedure.The patient remained on cardiopulmonary bypass throughout the procedure without intervention.There was a reported delay that resulted in no patient consequences.
 
Manufacturer Narrative
An event of the orifice being fractured and the disk being stuck was reported.The investigation found that the orifice was fractured near the one pivot guard of the valve.The piece of the orifice that had fractured was returned and was of an irregular shape.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, there was no evidence of the material defect in the carbon coating that may have caused or contributed to the damaged orifice.The damage may have been caused by some external force applied to the valve which overstressed the carbon material.Please note per the instructions for use, " the valve should rotate freely.If resistance is noted, the valve holder/rotator may not be properly seated in the valve, the valve may not be in the fully closed position, or the valve may be oversized.If the valve does not rotate freely, do not force valve rotation.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
REGENT HEART VALVE WITH FLEX CUFF
Type of Device
HEART-VALVE, MECHANICAL
Manufacturer (Section D)
ABBOTT MEDICAL
5050 nathan lane n
plymouth MN 55442
Manufacturer (Section G)
ST. JUDE MEDICAL PUERTO RICO, INC. REG#2648612
20 b st caguas west park
caguas 00725
*   00725
Manufacturer Contact
karen krouse
5050 nathan lane n
plymouth, MN 55442
6517565400
MDR Report Key18915823
MDR Text Key337808337
Report Number2135147-2024-01152
Device Sequence Number1
Product Code LWQ
UDI-Device Identifier05414734005852
UDI-Public05414734005852
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
P810002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 03/15/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number19AGFN-756
Device Lot Number31504411
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/21/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/08/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age64 YR
Patient SexFemale
-
-