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

Catalog Number 21AGFN-756

Device Problems Product Quality Problem (1506); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/08/2021

Event Type  malfunction  

Event Description

Size 21 st.Jude mechanical heart valve was opened to the field; after being opened and while waiting to sew in; it was noticed that the valve had become disconnected from its ring holder making it unable to be used.It became disconnected in package and was not identified until opened to sterile field.Ref: (b)(4).

• Brand Name: SJM REGENT
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 12868723
• MDR Text Key: 281214770
• Report Number: 12868723
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 21AGFN-756
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/06/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19345 DA
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Race: White