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

Model Number	21AGN-751
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/07/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, a 21mm regent heart valve was chosen for implant.After the physician placed the sutures on the valve, the leaflet dislodged from the valve without any force.The valve was removed and replaced with another 21mm regent heart valve to complete the procedure.The patient is reported to be stable.Although no patient consequences were reported, the procedure time was extended by 30 minutes.
Event or Problem Description
On (b)(6) 2018, a 21mm regent heart valve was chosen for implant.After the physician placed the sutures on the valve, the leaflet dislodged from the valve without any force when the valve was being positioned in the annulus.The holder handle/rotator was used while the sutures were being attached to the valve and during positioning.The valve was removed and replaced with another 21mm regent heart valve to complete the procedure.The patient is reported to be stable.Although no patient consequences were reported, the procedure time was extended by 30 minutes.
Additional Manufacturer Narrative
The reported event of a dislodged leaflet was confirmed.One leaflet had dislodged from the returned valve.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the dislodgement remains unknown.

• 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: 7662762
• Report Number: 2648612-2018-00052
• Device Sequence Number: 2501534
• Product Code: LWQ
• UDI-Device Identifier: 05414734005982
• UDI-Public: 05414734005982
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/07/2022
• Device Model Number: 21AGN-751
• Device Catalogue Number: 21AGN-751
• Device Lot Number: 6240942
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/11/2018
• Supplement Date Received by Manufacturer: 07/27/2018
• Initial Report FDA Received Date: 07/04/2018
• Supplement Report FDA Received Date: 08/13/2018
• 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: Other
• Patient Age: 63 YR