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

Model Number	15MHPJ-505
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2017, a 15mm masters plus valve was implanted in a pediatric patient.On (b)(6) 2019, the 2 year old valve was explanted and replaced with a larger 19mm masters mechanical heart valve (serial number: (b)(4)) due to patient growth.The patient is reported to be stable.(clinical study patient id: (b)(6)).
Additional Manufacturer Narrative
An event of valve explant due to patient growth was reported.The results of the investigation are inconclusive since the device remains implanted 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 at the time of commercialization.There was no evidence of device malfunction, and the valve was replaced with a larger, 19mm, valve.
Event or Problem Description
On (b)(6) 2017, a 15mm masters plus valve was implanted in a pediatric patient.On (b)(6) 2019, the 2 year old valve was explanted and replaced with a larger 19mm masters mechanical heart valve (serial number: (b)(4)) due to patient growth.The patient is reported to be stable.(clinical study patient id: (b)(4).

• Brand Name: SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE
• 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: 8489745
• Report Number: 3007113487-2019-00006
• Device Sequence Number: 16843724
• Product Code: LWQ
• UDI-Device Identifier: 05415067016522
• UDI-Public: 05415067016522
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2019

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: 05/10/2017
• Device Model Number: 15MHPJ-505
• Device Catalogue Number: 15MHPJ-505
• Device Lot Number: 3698011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 04/11/2019; 09/03/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 04/23/2019; 10/02/2019
• 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: 2 YR
• Patient Weight: 11