MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (CS-WOODRIDGE) SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE; HEART-VALVE, MECHANICAL

Model Number	15MHPJ-505
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	09/10/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Further information regarding this event has been requested.Investigation results will be provided in a subsequent submission.
Event or Problem Description
It was reported that a patient who had received a 15 mm masters aortic valve and a 15mm and 17mm masters mitral valve died on (b)(6) 2020 of unknown causes.As there is not enough information to determine relation to the abbott devices, this event is being conservatively reported.On (b)(6) 2017 a 15mm sjm masters series hemodynamic plus valve mitral valve was implanted.On (b)(6) 2017 the patient underwent an implant procedure of a 15 mm aortic valve, 15 ahpj-505.Post implant, in 2018, the patient was treated for a variety of comorbidities including "failure to thrive" requiring a feeding tube, c-diff infection and recurrent bronchiolitis.On (b)(6) 2020, the 15 mm masters valve was exchanged with a 17 mm sjm masters series hemodynamic plus mitral valve.Since the implant of the 17mm valve, the patient developed complete heart block, suffered cardiac arrest, a subdural hematoma, severe renal failure, pancreatitis and bacterial pneumonia.On (b)(6) 2020 the patient was brought in for an unrelated procedure which identified an "obstructed circumflex artery." it was determined the obstruction was secondary to compression of the 17mm mitral valve.The site reported the patient¿s death occurred on (b)(6) 2020.Additional information has been requested to determine cause of death.Us0545-4,crd 945, s554619101,s538340301,s536621601.
Additional Manufacturer Narrative
Additional information was received from the implanting physician confirming the patient's death was due to the patient's many co morbidities and pre-existing conditions and not due to the abbott device.This event was conservatively reported pending additional information and is no longer reportable as the presence of the abbott device did not result in patient injury or death.Additionally no intervention was performed to prevent permanent impairment or damage and no device malfunction was reported.

• Brand Name: SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (CS-WOODRIDGE); 177 east county road b; st. paul MN 55117
• MDR Report Key: 10722336
• Report Number: 3007113487-2020-00033
• Device Sequence Number: 1139816
• Product Code: LWQ
• UDI-Device Identifier: 05415067016522
• UDI-Public: 05415067016522
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/06/2020
• Device Model Number: 15MHPJ-505
• Device Catalogue Number: 15MHPJ-505
• Device Lot Number: 5320414
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/25/2020
• Supplement Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 10/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 8