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

Model Number 23MECJ-502

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, a 23mm masters series valve was selected for implant.After cutting the retaining sutures of the valve holder, one of the leaflets was closed, obliquely placed, and non-moving.When the valve was rotated using the valve holder handle, one of leaflets broke in two pieces.Upon explant of the valve, the second leaflet was found dislodged.All of the pieces were successfully removed from the patient.The surgeon made the native mitral annulus a little larger and implanted a 25mm masters series valve.Although no serious injury occurred, the procedure time was extended by one hour.The patient has been transferred to the icu in stable condition.

Manufacturer Narrative

An event of an extended procedure due to leaflet fracture and dislodgement was reported.The leaflet fracture and dislodgement was confirmed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Information from the field indicated that the valve was rotated with one leaflet in the open position.Per the instructions for use, to avoid structural damage the valve must be rotated in a fully closed position.The cause of the fixed leaflet remains unknown.Subsequently, the surgeon enlarged the native mitral annulus and a larger, 25mm masters series valve was implanted.

Event Description

On (b)(6) 2018, a 23mm masters series valve was selected for implant in the mitral annulus.After cutting the retaining sutures of the valve holder, one of the leaflets was open, obliquely placed, and non-moving.When the valve was rotated with the leaflet open using the valve holder handle, the leaflet broke in two pieces.Upon explant of the valve, the second leaflet was found dislodged.All pieces of the broken leaflets were successfully removed from the patient.The surgeon made the native mitral annulus a little larger and implanted a 25mm masters series valve.Although no serious injury occurred, the procedure time was extended by one hour.The patient has been transferred to the icu in stable condition.Per the ifu: to avoid structural damage the valve must be rotated in a fully closed position.

• Brand Name: SJM MASTERS SERIES VALVE EXPANDED 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: 7512737
• MDR Text Key: 108224298
• Report Number: 2648612-2018-00033
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2023
• Device Model Number: 23MECJ-502
• Device Catalogue Number: 23MECJ-502
• Device Lot Number: 6330453
• Other Device ID Number: 05414734006170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Weight: 42