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

Model Number 21AECJ-502

Device Problems Material Separation (1562); Device Dislodged or Dislocated (2923)

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

Event Date 01/31/2021

Event Type  malfunction  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2021, a 21 mm sjm masters series valve expanded cuff was selected for implant.While placing the valve one of the leaflets dislodged.The valve was successfully removed and replaced with a 19 mm sjm masters series valve expanded cuff.There was a clinically significant delay in procedure.The patient was reported to be in stable.

Manufacturer Narrative

The reported event of the leaflet dislodging could not be confirmed.A more comprehensive assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.Please note, per the masters series instructions for use artmt100122073 revision 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.".

Manufacturer Narrative

Additional information: d9, h3, h6.The reported event of a dislodged leaflet was confirmed.One leaflet was fractured and dislodged from the orifice.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.While the root cause of the leaflet dislodgement could not be conclusively determined, there was no evidence of material defect in the carbon coating that may have caused or contributed to the dislodged leaflets.The damage may have been caused by some external force applied to the valve which overstressed the carbon material.

• 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
• MDR Report Key: 11337251
• MDR Text Key: 232163085
• Report Number: 2648612-2021-00010
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734053884
• UDI-Public: 05414734053884
• Combination Product (y/n): N
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21AECJ-502
• Device Catalogue Number: 21AECJ-502
• Device Lot Number: 7411987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 02/17/2021
• Supplement Dates Manufacturer Received: 05/27/2021; 09/27/2021
• Supplement Dates FDA Received: 06/01/2021; 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR