MAUDE Adverse Event Report: ST. JUDE MEDICAL SJM MASTERS SERIES MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Model Number	33MJ-501
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, a 33mm masters valve was selected for implant in the mitral position.The valve was rotated initially with the valve rotator followed by forceps.During this rotation, both leaflets dislodged and one fractured into multiple pieces.The valve was explanted and the leaflet and fractured pieces were successfully retrieved, extending the procedure time by one hour.The device was exchanged for a 33 masters valve and was successfully implanted.The patient remained hemodynamically stable and there were no adverse patient consequences.
Event or Problem Description
On (b)(6) 2018, a 33mm masters valve was selected for implant in the mitral position.The valve was rotated initially with the valve rotator followed by forceps.During this rotation, both leaflets dislodged and one fractured into multiple pieces.There was no sub-annular tissue that limited the ability to rotate.The valve was explanted and the leaflet and fractured pieces were successfully retrieved, extending the procedure time by one hour.The device was exchanged for a 33 masters valve and was successfully implanted with pledgets.The patient remained hemodynamically stable and there were no adverse patient consequences.
Additional Manufacturer Narrative
The reported event of a fractured and dislodged leaflets was confirmed.One leaflet was fractured and dislodged from the orifice, but was not returned to abbott in its entirety.Though this leaflet was not returned in its entirety, abbott received confirmation that all pieces of the leaflet were successfully retrieved.The other leaflet was dislodged from the orifice and intact.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.There was no evidence of material defect in the carbon coating that may have caused or contributed to the dislodged leaflet or orifice damage.However, the damage was consistent with some external force applied to the valve which overstressed the carbon material.The cause of the reported event remains unknown.Please note, per the instructions for use, artmt100122073 ver.A, "using the valve holder/rotator and an sjm¿ valve holder handle, rotate the valve in situ to the desired position.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.".
Event or Problem Description
On (b)(6) 2018, a 33mm masters valve was selected for implant in the mitral position.The valve was rotated initially with the valve rotator followed by forceps.During this rotation, both leaflets dislodged and one fractured into multiple pieces.There was no sub-annular tissue that limited the ability to rotate.The valve was explanted and the leaflet and fractured pieces were successfully retrieved, extending the procedure time by one hour and the bypass time by 3 hours.The device was exchanged for a 33 masters valve and was successfully implanted with pledgets.The patient remained hemodynamically stable and there were no adverse patient consequences.

• Brand Name: SJM MASTERS SERIES MECHANICAL HEART VALVE
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• MDR Report Key: 8210516
• Report Number: 2648612-2018-00106
• Device Sequence Number: 265059
• Product Code: LWQ
• UDI-Device Identifier: 05414734006682
• UDI-Public: 05414734006682
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/04/2019

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: 06/08/2021
• Device Model Number: 33MJ-501
• Device Lot Number: 5534308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/14/2018
• Supplement Date Received by Manufacturer: 01/04/2019; 02/12/2019
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 01/23/2019; 03/04/2019
• 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: Required Intervention