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

Model Number	25AJ-501
Medical Device Problem Codes	Biocompatibility (2886); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	09/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
It was reported that a 25mm sjm masters series mechanical heart valve was implanted on (b)(6) 2021.Post procedure, the valve leaflets could not open and close normally after implant related to thrombosis.It was noted that the patient has had a previous stroke and insufficient anticoagulation.There was no patient anatomy interference that could have caused the incomplete coaptation.It was reported that there was some abnormalities with the valve but details were not provided.Device was replaced with a new 25mm sjm masters series mechanical heart valve that was implanted on (b)(6) 2021.It was reported that the patient did not remain hemodynamically stable throughout the procedure.There was a clinically significant delay in the procedure due to this event.No additional information was provided.
Additional Manufacturer Narrative
Additional information sections: b5, d9, h1, h2, h3, h6, h10.An event of the "leaflets could not open and close normally" was reported.Morphological and hydrodynamic examination indicated the valve met abbott specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Hydrodynamic testing upon return to abbott and at the time of manufacturing indicated the valve functioned normally.This test ensures proper leaflet coaptation and hemodynamic performance.The cause of the reported event could not be conclusively determined.
Event or Problem Description
It was reported that a 25mm sjm masters series mechanical heart valve was implant on (b)(6) 2021.Post procedure, the valve leaflets could not open and close normally after implant related to thrombosis.It was noted that the patient has had a previous stroke and insufficient anticoagulation.The patient took warfarin antithrombotic medication.According to the physician, the patient may have high anticoagulant blood diseases.At present, the international inr anticoagulation requirements are in the range of 1.6-2.1.There was no patient anatomy interference that could have caused the incomplete coaptation.There were no other abnormalities in the valve except that the leaflets could not be opened and closed normally.Device was replaced with a new 25mm sjm masters series mechanical heart valve that was implanted on (b)(6) 2021.It was reported that the patient did not remained hemodynamically stable throughout the procedure.There was a clinically significant delay in the procedure due to this event.No additional information was provided.

• Brand Name: SJM MASTERS SERIES MECHANICAL HEART VALVE
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12691401
• Report Number: 3007113487-2021-00075
• Device Sequence Number: 19831289
• Product Code: LWQ
• UDI-Device Identifier: 05414734021128
• UDI-Public: 05414734021128
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 12/15/2021

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: 01/21/2026
• Device Model Number: 25AJ-501
• Device Catalogue Number: 25AJ-501
• Device Lot Number: 7812950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• 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: 09/29/2021
• Supplement Date Received by Manufacturer: 11/25/2021
• Initial Report FDA Received Date: 10/25/2021
• Supplement Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2021
• 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