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

Model Number 23MJ-501

Device Problem Biocompatibility (2886)

Patient Problems Dyspnea (1816); Thrombosis/Thrombus (4440)

Event Date 01/28/2021

Event Type  Injury  

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 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.

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.

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
• Type of Device: 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
• MDR Text Key: 231127060
• Report Number: 3008452825-2021-00087
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006187
• UDI-Public: 05414734006187
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 30 YR
• Patient Sex: Female