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

Model Number	27MJ-501
Medical Device Problem Codes	Obstruction of Flow (2423); Biocompatibility (2886)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	12/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
It was reported during a follow-up in the clinic the patient presented shortness of breath and chest pain.Upon further evaluation, it was discovered the patient had a "stuck" valve due to thrombus formation.The cause of the thrombus formation is due to the patients non-compliance with their prescribed anticoagulant therapy.The patient has also not had their inr followed as required.No additional information has been provided.On (b)(6) 2021, the patient underwent an explant procedure of the 27mm sjm masters series mechanical heart valve and it was replaced with a non-abbott device.The patient remained stable throughout the procedure.No additional information has been provided.
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
It was reported during a follow-up in the clinic the patient presented shortness of breath and chest pain.Upon further evaluation, it was discovered the patient had a "stuck" valve due to thrombus formation.The cause of the thrombus formation is due to the patients non-compliance with their prescribed anticoagulant therapy.The patient has also not had their inr followed as required.No additional information has been provided.On (b)(6) 2021, the patient underwent an explant procedure of the 27mm sjm masters series mechanical heart valve and it was replaced with a non-abbott device.The patient remained stable throughout the procedure.No additional information has been provided.
Additional Manufacturer Narrative
Additional information: g3,g6, h2, h6, h10.An event of the valve leaflets being stuck due to thrombus formation 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, however it was noted that the patient was non-compliant with their anti-coagulation therapy and that their inr had not been followed.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13286385
• Report Number: 2648612-2022-00007
• Device Sequence Number: 4599261
• Product Code: LWQ
• UDI-Device Identifier: 05414734006460
• UDI-Public: 05414734006460
• 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 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
• Report Date (Section B): 03/12/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/06/2023
• Device Model Number: 27MJ-501
• Device Catalogue Number: 27MJ-501
• Device Lot Number: 6311313
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2021
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 01/18/2022
• Supplement Report FDA Received Date: 03/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2018
• 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: Required Intervention
• Patient Sex: Unknown