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

Model Number	25AGFN-756
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2018, an aortic valve replacement procedure was performed and a 25mm regent valve was implanted.During suturing, a leaflet of the valve dislodged and fell into the left ventricle.Dissection of the left atrium was performed to remove the leaflet.The leaflet was observed to be in the left pulmonary vein and was removed using a forceps.The device was explanted and exchanged for a carbomedics orbis valve (size unknown) and the procedure was completed with no further issues.The patient is reported to be stable.
Additional Manufacturer Narrative
The reported event of a dislodged leaflet was confirmed.On leaflet was dislodged from the orifice and returned with the valve.No other damage was noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.The cause of the leaflet dislodgment could not be conclusively determined.Per the site, the leaflet dislodged while testing the valve.Please note per the instructions for use, artmt 100078770 revision b, "do not use hard or rigid instruments to test leaflet mobility, as this may result in structural damage to the valve or thromboembolic complications.Use a st.Jude medical leaflet tester to gently test valve leaflet mobility.".
Event or Problem Description
On (b)(6) 2018, an aortic valve replacement procedure was performed and a 25mm regent valve was implanted.During testing of the valve, a leaflet of the valve dislodged and fell into the left ventricle.Dissection of the left atrium was performed to remove the leaflet.The leaflet was observed to be in the left pulmonary vein and was removed using a forceps.The physician confirmed that no leaflet pieces remained in the patient following removal.The device was explanted and exchanged for a 25mm carbomedics orbis valve and the procedure was completed with no further issues.Per the site, the patient remained hemodynamically stable throughout the procedure; however, the procedure time was significantly extended due to the valve replacement.The patient is reported to be stable.

• Brand Name: SJM REGENT HEART VALVE W/FLEX CUFF
• 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: 8773997
• Report Number: 2648612-2019-00054
• Device Sequence Number: 1489768
• Product Code: LWQ
• UDI-Device Identifier: 05414734006262
• UDI-Public: 05414734006262
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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: foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/23/2023
• Device Model Number: 25AGFN-756
• Device Catalogue Number: 25AGFN-756
• Device Lot Number: 6707709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 09/10/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 36 YR
• Patient Weight: 75