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

Model Number 27MJ-501

Device Problems Obstruction of Flow (2423); Biocompatibility (2886)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 12/27/2021

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event 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.

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 285334706
• Report Number: 2648612-2022-00007
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006460
• UDI-Public: 05414734006460
• 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
• Report Date: 03/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2018
• 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): Required Intervention