MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA (SH) SJM MASTERS SERIES MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Model Number	23MJ-501
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Dyspnea (1816); Thrombosis/Thrombus (4440)
Date of Event	01/28/2021
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) 2020, a 23mm sjm masters series mechanical heart valve was implanted.The patient presented with breathing difficulties and a valve thrombosis was noted.The valve was explanted on (b)(6) 2021, upon explant a thrombus was noted in the hinge area.A 25mm epic stented porcine heart valve w/flexfit system was successfully implanted.The patient was reported to be in stable condition.
Additional Manufacturer Narrative
An event of valve thrombosis was reported.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.
Additional Manufacturer Narrative
Explant was reported due to valve thrombosis.The investigation found that there was a thin film of debris containing yeast forms on the surface of one mechanical leaflet.One leaflet was dislodged and fractured into two pieces.No inflammation or significant calcifications were present.The device history record was reviewed to ensure each manufacturing and inspection operation was performed, and the product met all specifications.The cause of reported event could not be conclusively determined.The leaflet fracture is consistent with damage at explant, and the thrombus noted at explant could not be confirmed.

• Brand Name: SJM MASTERS SERIES MECHANICAL HEART VALVE
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA (SH); parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 01897 -405; CS 01897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL, COSTA RICA LTDA (SH); parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 01897 -405; CS 01897-4050
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 11306964
• Report Number: 3008452825-2021-00087
• Device Sequence Number: 2660747
• Product Code: LWQ
• UDI-Device Identifier: 05414734006187
• UDI-Public: 05414734006187
• 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: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/06/2022

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: 12/14/2023
• Device Model Number: 23MJ-501
• Device Catalogue Number: 23MJ-501
• Device Lot Number: 6780738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/06/2021
• Supplement Date Received by Manufacturer: 05/27/2021; 12/28/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 06/01/2021; 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 30 YR
• Patient Sex: Female