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

Model Number	25M-101
Medical Device Problem Codes	Obstruction of Flow (2423); Incomplete Coaptation (2507)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	07/26/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2009, a 25mm mitral valve was implanted.On (b)(6) 2019, the patient was having difficult in breathing.The leaflet on the valve was found to be "stuck," it was not moving freely and it was obstructing.The valve was replaced with another 25mm master mitral valve (sn: (b)(4)).
Additional Manufacturer Narrative
An event of a leaflet being stuck on mechanical valve and valve explant was reported.The results of the investigation are inconclusive since 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.

• Brand Name: SJM MECHANICAL HEART VALVE
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• MDR Report Key: 9107609
• Report Number: 2648612-2019-00080
• Device Sequence Number: 16765889
• Product Code: LWQ
• UDI-Device Identifier: 05414734006323
• UDI-Public: 05414734006323
• 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 Implanted Year: 2009
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2020

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 Model Number: 25M-101
• Device Catalogue Number: 25M-101
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/26/2019
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 02/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 23 YR