MAUDE Adverse Event Report: ABBOTT MEDICAL MASTERS SERIES HEMODYNAMIC PLUS VALVE; HEART-VALVE, MECHANICAL

Model Number	19AHPJ-505
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Insufficient Information (4580)
Date of Event	08/28/2022
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2022, a 19mm sjm masters series hemodynamic plus valve was selected for implant.It was noted that during procedure the leaflets of the valve were not coapting properly.The decision was made to explant the 19mm masters valve and replace it with a 17mm regent valve.Due to an unknown reason the patient was pronounced deceased.No additional information was provided.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of leaflets of the valve not coapting properly and patient death was reported.A more comprehensive assessment, including a histopathological examination of the valve, 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.H6 health effect - clinical code: 4580 code removed death date is estimated.
Event or Problem Description
It was reported that on (b)(6) 2022, a 19mm sjm masters series hemodynamic plus valve was selected for implant.It was noted that during procedure the leaflets of the valve were not coapting properly.The decision was made to explant the 19mm masters valve and replace it with a 17mm regent valve.Due to an unknown reason the patient was pronounced deceased.No additional information was provided.Subsequent to the previously filed reported, additional information was received that 19mm sjm masters series hemodynamic plus valve had been sized using an unknown sizer set.It was visually noted during the procedure, that the 19mm sjm masters series hemodynamic plus valve was not opening completely.The valve had been implanted into the patient's aortic valve.The patient had not been removed off cardiopulmonary bypass (cpb) and then put back on cpb for further intervention.The cardiopulmonary bypass/cross-clamp time had not been significantly extended due to this event.It was noted that the reason for selecting a smaller 17mm sjm regent heart valve with flex cuff as the replacement was because of the larger 19mm sjm masters series hemodynamic plus valve not coapting properly.It was also noted that the patient was stable prior to procedure.There had been no noted difficulty implanting the 17mm sjm regent heart valve with flex cuff.The patient had remained hemodynamically stable throughout the procedure.There was no clinically significant delay in the implant procedure reported.At an unknown point the patient suffered cardiac arrest.Cardiopulmonary resuscitation was attempted, but was unsuccessfully.The direct cause of the patient's cardiac/death is unknown, but is believed to be in relation the patient's previous comorbidities.No additional information was provided.

• Brand Name: MASTERS SERIES HEMODYNAMIC PLUS VALVE
• 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: 15474111
• Report Number: 2135147-2022-01339
• Device Sequence Number: 2873541
• Product Code: LWQ
• UDI-Device Identifier: 05414734005883
• UDI-Public: 05414734005883
• Combination Product (Y/N): N
• Initial Reporter Country: BG
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 01/10/2023

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 Model Number: 19AHPJ-505
• Device Catalogue Number: 19AHPJ-505
• Device Lot Number: C00001348
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/28/2022
• Supplement Date Received by Manufacturer: 12/30/2022
• Initial Report FDA Received Date: 09/23/2022
• Supplement Report FDA Received Date: 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown