MAUDE Adverse Event Report: ABBOTT MEDICAL MASTERS SERIES VALVE EXPANDED CUFF; HEART-VALVE, MECHANICAL

Model Number 19AECJ-502

Device Problems Fracture (1260); Physical Resistance/Sticking (4012)

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

Event Date 04/26/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6) 2023 a 19mm sjm masters series valve w/ expanded cuff was chosen for implant.The patient's aortic annulus was sized 19mm via a mechanical sizer set.After the device was implanted, the operator attempted to rotate the valve in situ, felt resistance, and was unable to rotate when one of the leaflets had fractured into three pieces.It was reported no other instruments encountered the valve at the time of fracture and all of the leaflet fractured pieces were removed from the patient.It was also reported only the holder handle was used to rotate the valve, the holder hander was fully inserted into the orifice at a 90 degree angle, and the valve was in a closed position when rotated.A decision was made to explant the valve and a new 19mm sjm masters series valve expanded cuff was implanted in the patient with no adverse patient consequences.There was no clinically significant delay in the procedure due to this event.The patient remained hemodynamically stable throughout the procedure and their status was reported as stable.

Manufacturer Narrative

The reported event of a dislodged leaflet was confirmed.One leaflet was fractured and dislodged from the orifice.No other damage was noted to the returned valve.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 leaflet or orifice damage.The damage may have been caused by some external force applied to the valve, which overstressed the carbon material.Please note, per the masters valve instructions for use, "valve rotation: 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.

• Brand Name: MASTERS SERIES VALVE EXPANDED CUFF
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC. REG#2648612; 20 b st caguas west park; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16969670
• MDR Text Key: 315949513
• Report Number: 2135147-2023-02229
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734053877
• UDI-Public: 05414734053877
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 19AECJ-502
• Device Catalogue Number: 19AECJ-502
• Device Lot Number: 8128805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2021
• 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 Age: 49 YR
• Patient Sex: Male
• Patient Weight: 57 KG