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

Model Number	19AJ-501
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019, a customer owned 19mm masters valve was implanted; however, the expiration date of the device was (b)(6) 2019.Additional information has been requested.
Event or Problem Description
On (b)(6) 2019, a customer owned 19mm masters valve was selected for implant.During device preparation, the device was confirmed to be expired with an expiration date of 09 january 2019.The physician elected to implant the device.The patient was informed and continues regular monitoring.
Additional Manufacturer Narrative
An event of use of expired product was reported.The results of the investigation confirmed that masters valve 83974925 expired on 09 january 2019 which was prior to the reported event date of (b)(6) 2019.A review of distribution records confirmed that this product was distributed prior to its expiration date.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, including verification of the expiration date listed on the product label.The root cause of the reported event is consistent with user error.Per the instructions for use, artmt100045600 version a,"warning: do not use the device if the expiration date has elapsed".

• Brand Name: SJM MASTERS SERIES 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: 8356540
• Report Number: 2648612-2019-00013
• Device Sequence Number: 16568381
• Product Code: LWQ
• UDI-Device Identifier: 05414734021098
• UDI-Public: 05414734021098
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2019

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: 01/09/2019
• Device Model Number: 19AJ-501
• Device Lot Number: 4413086
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 02/20/2019
• Supplement Report FDA Received Date: 03/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other