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	Obstruction of Flow (2423)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Mitral Valve Stenosis (1965)
Date of Event	06/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of explant of the valve and replacement with a larger valve due to stenosis and pulmonary hypertension 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.
Event or Problem Description
On (b)(6) 2017, a 15mm masters mitral valve was implanted.On (b)(6) 2020, the patient was admitted for planned mitral valve repair due to worsening mitral valve stenosis and pulmonary hypertension.On (b)(6) 2020, the mitral valve was explanted and a new 17mm masters mitral valve was successfully implanted.On (b)(6) 2020, the patient developed first degree heart block, complete heart block, and junctional rhythm.Therefore, on (b)(6) 2020, an epicardial pacemaker was implanted.The patient is reported to be recovering.Clinical study patient id: (b)(6).

• 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: 10333041
• Report Number: 3007113487-2020-00018
• Device Sequence Number: 19726328
• Product Code: LWQ
• UDI-Device Identifier: 05415067016522
• UDI-Public: 05415067016522
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/28/2020

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?: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/28/2020
• 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: 4 YR
• Patient Weight: 14