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

Model Number	19AECJ-502
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 2135147-2023-02229
• Device Sequence Number: 12125666
• Product Code: LWQ
• UDI-Device Identifier: 05414734053877
• UDI-Public: 05414734053877
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/07/2026
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 57 KG