MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. SJM MECHANICAL HEART VALVE (UNKNOWN); HEART-VALVE, MECHANICAL

Model Number 25A-101

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/23/2019

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

In 1985, a 25 mm sjm mechanical heart valve was implanted.On (b)(6) 2019, the valve was explanted.The user reported no device malfunction and noted that the leaflets of the valve appeared pristine and able to move freely.Below the mitral valve, the physician observed a fibrocalcific ring with a reduced orifice suspected to be the result of pannus formation and calcification.

Manufacturer Narrative

Explant was reported due to "pseudo-mitral stenosis secondary to postvalvar obstruction with normally functioning st.Jude prosthesis¿.The investigation confirmed that both leaflets opened and closed completely and easily.There was fibrous pannus limited to the sewing cuff.No inflammation or significant calcifications were present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.The cause of the reported event could not be conclusively determined.

Manufacturer Narrative

Explant was reported due to "pseudo-mitral stenosis secondary to postvalvar obstruction with normally functioning st.Jude prosthesis¿.The investigation confirmed that both leaflets opened and closed completely and easily.There was fibrous pannus limited to the sewing cuff.No inflammation or significant calcifications were present.The cause of the reported event could not be conclusively determined, however, per the site the user reported no device malfunction.

Event Description

In 1985, a 25mm sjm mechanical heart valve was implanted.On (b)(6) 2019, the valve was explanted.The user reported no device malfunction and noted that the leaflets of the valve appeared pristine and able to move freely.Below the mitral valve, the physician observed a fibrocalcific ring with a reduced orifice suspected to be the result of pannus formation and calcification.No patient consequences were reported.

• Brand Name: SJM MECHANICAL HEART VALVE (UNKNOWN)
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one lillehei plaza; lot 20 b st.; st. paul MN 55117
• MDR Report Key: 8724686
• MDR Text Key: 148911986
• Report Number: 2648612-2019-00045
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/08/1999
• Device Model Number: 25A-101
• Device Catalogue Number: 25A-101
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 83