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

Model Number 23AFHPJ-505

Device Problem Use of Device Problem (1670)

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

Event Date 01/16/2016

Event Type  Injury  

Event Description

On (b)(6) 2016, a 25mm masters valve was implanted.Following the implant procedure, it was identified the device was implanted after the expiration date.The patient has experienced no adverse consequences since the device has been implanted.

Manufacturer Narrative

An event of implant of a valve after the expiration date was reported.The results of the investigation confirmed that masters valve (b)(4) expired on (b)(6) 2015 which was prior to the reported event date of 16 january 2016.A review of distribution records confirmed that this product was distributed to the hospital on (b)(6) 2015, 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.

• Brand Name: SJM MASTERS SERIES MECHANICAL HEART VALVE
• Type of Device: 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: 8896729
• MDR Text Key: 154412662
• Report Number: 2648612-2019-00061
• 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
• Report Date: 10/07/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2010
• Device Model Number: 23AFHPJ-505
• Device Catalogue Number: 23AFHPJ-505
• Device Lot Number: 0002099488
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/18/2019
• Initial Date FDA Received: 08/15/2019
• Supplement Dates Manufacturer Received: 09/19/2019
• Supplement Dates FDA Received: 10/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR