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

Model Number	19AECJ-502
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
It was reported that on (b)(6) 2021 a 19 mm sjm masters series valve expanded cuff was chosen for procedure.During the implantation of the device, one leaflet dislodged during rotation.The user reported the issue occurred mainly due to the patients anatomy.The patient had sever aortic stenosis (as) with sub-aortic membrane.There was a 3 layer membrane and it was fused, due to the force, it had dislodged.The device was removed and replaced with a new, 21 mm sjm masters series valve expanded cuff valve.The patient was not stable during the procedure or after the procedure.Despite limited health history, the patients post-op bilirubin was high, and the patient required 12 pints of blood.The patients serum glutamic-pyruvic transaminase (sgpt) was also high but it remains unknown if the patient had underlying liver disease.The physician did not mention that the complications were due to valve dislodgement.The patient required prolonged hospitalization however, according to the physician the event was not due to the valve.No additional information has been provided.
Event or Problem Description
Subsequently to the initially filed information, the following information was confirmed."the device was removed and all leaflets were retrieved.".
Additional Manufacturer Narrative
An event of; leaflet dislodgment during rotation was reported.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.
Additional Manufacturer Narrative
The reported event of a dislodged leaflet was confirmed.On leaflet and fractured was dislodged from the orifice and returned with the 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.The damage may have been caused by some external force applied to the valve which overstressed the carbon material.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.".

• Brand Name: SJM MASTERS SERIES VALVE EXPANDED CUFF
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• MDR Report Key: 12376988
• Report Number: 3007113487-2021-00021
• Device Sequence Number: 1206961
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/04/2026
• Device Model Number: 19AECJ-502
• Device Catalogue Number: 19AECJ-502
• Device Lot Number: 7872583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/31/2021
• Supplement Date Received by Manufacturer: 09/14/2021; 10/25/2021
• Initial Report FDA Received Date: 08/27/2021
• Supplement Report FDA Received Date: 09/19/2021; 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 50