MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM REGENT HEART VALVE W/FLEX CUFF; HEART-VALVE, MECHANICAL

Model Number 27AGFN-756

Device Problem Device Expiration Issue (1216)

Patient Problem Endocarditis (1834)

Event Date 10/23/2007

Event Type  Injury  

Manufacturer Narrative

An event of valve explant due to endocarditis 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.Based on the information received, the cause of the reported incident could not be conclusively determined.It should be noted that the reported incident date was after the product "use by"/"use before" date.

Event Description

On (b)(6) 2007, a 27mm sjm regent heart valve was implanted.On (b)(6) 2017, the valve was explanted due to endocarditis.During the investigation of the explant, internal manufacturing records showed that the explanted device was implanted 10 months after its use by date of (b)(6) 2007.Abbott requested the implanting md review hospital medical records and to confirm the serial number and use by date.After review, the md confirmed that the internal information was accurate and at the time of initial implant, the hospital only stocked single sizes of valves and the expired valve was the only 27mm valve available for implant.

• Brand Name: SJM REGENT HEART VALVE W/FLEX CUFF
• 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
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7412451
• MDR Text Key: 104878678
• Report Number: 2648612-2018-00030
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2007
• Device Model Number: 27AGFN-756
• Device Catalogue Number: 27AGFN-756
• Device Lot Number: 0002636354
• Other Device ID Number: 81646879
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2002
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR