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

Model Number 17MHPJ-505

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 04/24/2019

Event Type  Injury  

Manufacturer Narrative

The reported event of a dislodged leaflet was confirmed.On leaflet was dislodged from the orifice and not returned with the valve.No other damage was noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.The cause of the leaflet dislodgment could not be conclusively determined.Please note, per the instructions for use artmt100045600 version a, "using the valve holder/rotator and an sjm valve holder handle, rotate the valve in situ to the desired position.The valve should rotate freely.If resistance is noted, the valve holder/ rotator may not be properly seated in the valve, the valve may not be in the fully closed position, or the valve may be oversized.If the valve does not rotate freely, do not force valve rotation.".

Event Description

On (b)(6) 2019, a mechanical valve replacement procedure was performed and a 17mm masters valve (serial number (b)(4)) was explanted and exchanged for a 23mm masters valve.After the valve was placed, the user attempted to rotate the valve and after rotation, a leaflet was observed to be detached from the valve.The physician opened the atrium and the left ventricle and was unable to recover the leaflet.No evidence of the detached leaflet was observed on x-ray and the user reports that no damage was observed in the retention pivot area.The device was removed and exchanged for a 25mm masters valve (serial number: (b)(4)).No patient consequences were reported and the patient has been discharged.

• Brand Name: SJM MASTERS SERIES HEMODYNAMIC PLUS 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
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8711835
• MDR Text Key: 148414497
• Report Number: 2648612-2019-00044
• 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: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2011
• Device Model Number: 17MHPJ-505
• Device Catalogue Number: 17MHPJ-505
• Device Lot Number: 0002611208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2007
• 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: 12 YR