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

Model Number	21AEHPJ-505
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event of a fracture during rotation could not be confirmed.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.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
On (b)(6) 2018, a 21mm sjm masters series expanded hemodynamic plus mechanical heart valve was selected for implant.Upon implant, one of the leaflets was not moving during leaflet check.Upon rotation, one of the leaflets fractured into multiple pieces.The valve was exchanged for another 21mm sjm masters series expanded hemodynamic plus mechanical heart valve (serial number: (b)(4)).The procedure was extended over 30 minutes and the patient is reported to be recovering.

• Brand Name: SJM MASTERS SERIES EXPANDED HEMODYNAMIC PLUS
• 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
• MDR Report Key: 7671435
• Report Number: 2648612-2018-00054
• Device Sequence Number: 1018507
• Product Code: LWQ
• UDI-Device Identifier: 05414734009584
• UDI-Public: 05414734009584
• Combination Product (Y/N): N
• Initial Reporter Country: TX
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Replace,Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 07/09/2018

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: 06/15/2020
• Device Model Number: 21AEHPJ-505
• Device Catalogue Number: 21AEHPJ-505
• Device Lot Number: 5128093
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2018
• Initial Report FDA Received Date: 07/09/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 100