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

Model Number	29MJ-501
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019, a 29 mm masters series mechanical heart valve was selected for implant.While rotating the valve, a leaflet dislodged.The leaflet and valve were removed and the device was exchanged with another masters valve.The patient remained hemodynamically stable, but it took an hour to arrange the replacement valve resulting in a clinically significant delay in the procedure.
Additional Manufacturer Narrative
The reported event of a dislodged leaflet was confirmed.One leaflet was dislodged from the orifice and fractured.The recessed pivot area was also chipped.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the leaflet dislodgment and fracture could not be conclusively determined.
Additional Manufacturer Narrative
An event of a dislodged leaflet was reported.The results of the investigation are inconclusive since 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 at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined.Please note, per the instructions for use artmt60008090 rev.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.".

• Brand Name: SJM MASTERS SERIES MECHANICAL 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: 9368733
• Report Number: 2648612-2019-00104
• Device Sequence Number: 11385275
• Product Code: LWQ
• UDI-Device Identifier: 05414734006552
• UDI-Public: 05414734006552
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/06/2020

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: 10/20/2023
• Device Model Number: 29MJ-501
• Device Catalogue Number: 29MJ-501
• Device Lot Number: 6701918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/17/2019
• Supplement Date Received by Manufacturer: 02/18/2020; 08/06/2020
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 02/18/2020; 08/06/2020
• 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 Weight: 67