MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM REGENT HEART VALVE; HEART-VALVE, MECHANICAL

Model Number	23AGN-751
Medical Device Problem Codes	Material Separation (1562); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
Related manufacturer reference number: 2648612-2021-00034.On (b)(6) 2021, a 23mm regent mechanical heart valve was selected for implant.Both leaflets of the valve became detached during typing of the valve sutures and fell into the left ventricle (lv) cavity.The valve was removed and both leaflets were retrieved from the lv; neither leaflets were reported to be fractured.A new 21mm regent mechanical heart valve was then implanted.As the physician was starting anatomy closure, one leaflet detached and fell into the lv cavity.The 21mm valve was also explanted and the leaflet was retrieved from the lv cavity; this leaflet was reported to have been fractured.A new competitor's on-x was successfully implanted.The physician alleged an increased pump time and the patient was "critical" after the procedure.Post-operatively, the patient was reported to be in stable condition.
Additional Manufacturer Narrative
The reported event of dislodged leaflets could not be confirmed.A more comprehensive assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.Information from the field indicated that a smaller, 21mm valve, was subsequently attempted to be implanted.This is possible evidence of oversizing.Please note, per the instructions for use, artmt600080902, rev.B, "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.".

• Brand Name: SJM REGENT HEART VALVE
• Common Device Name: 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 Key: 11596135
• Report Number: 2648612-2021-00033
• Device Sequence Number: 14509312
• Product Code: LWQ
• UDI-Device Identifier: 05414734006101
• UDI-Public: 05414734006101
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/09/2025
• Device Model Number: 23AGN-751
• Device Catalogue Number: 23AGN-751
• Device Lot Number: 7619232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 06/03/2021; 09/22/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 06/10/2021; 09/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR