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

Model Number 25AGFN-756

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2018

Event Type  Injury  

Manufacturer Narrative

The reported event of a dislodged leaflet was not confirmed, but a majority portion of one leaflet had broken off.Morphological examination revealed the leaflet had fractured, with the thin portion between the leaflet's two ears remaining properly inserted into the recessed pivot areas.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown; however, it is consistent with an external force applied to the leaflet and orifice, which overstressed the carbon material and resulted in the damage.

Event Description

A 25mm regent valve was implanted in the aortic position.The patient was on bypass and was heavily anti-coagulated at the time of implantation.The act/ ptt was monitored closely and maintained in lieu of the inr for cpb.Once the valve was sewn into the annulus, the surgeon attempted to rotate the valve with st.Jude valve rotator.During rotation one of the leaflets dislodged intact.The leaflet was safely removed from the patient and the valve was replaced with a 25mm masters series valved graft conduit.Cross-clamp time was extended but the cpb time was not extended.The user reported in his experience there was no delay in the procedure due to this event.The patient is reported to be recovering post-operatively.

• 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: 7263437
• MDR Text Key: 99803132
• Report Number: 2648612-2018-00013
• 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: Physician
• Type of Report: Initial
• Report Date: 02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2022
• Device Model Number: 25AGFN-756
• Device Catalogue Number: 25AGFN-756
• Device Lot Number: 5998600
• Other Device ID Number: 05414734006262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2017
• 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: 51 YR
• Patient Weight: 109