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

Model Number	17MHPJ-505
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/06/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, a 17mm master series valve was implanted in an infant patient.On (b)(6) 2018, the valve was explanted and replaced with a second 17mm mechanical heart valve.Additional information has been requested.
Additional Manufacturer Narrative
An event of an explanted valve was reported.Morphological and histopathological examination revealed limited mobility of both leaflets due to organizing thrombus in the recessed pivot areas.There were entrapped inflammatory cells within the thrombus, but no true inflammation.Pannus encroached onto both orifice rim sections.No calcifications were present in the attached tissue.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the organizing thrombus remains unknown without further information regarding patient comorbidities.
Event or Problem Description
On (b)(6) 2018, a 17 mm master series valve was implanted in an infant patient.On (b)(6) 2018, the valve was explanted and replaced with a second 17 mm mechanical heart valve.Additional information was requested, but not provided by the physician or hospital.
Additional Manufacturer Narrative
Additional information received on explant of second valve and implant of a third valve.Note: information regarding the second valve and third valve will be reported under (b)(4).
Event or Problem Description
On (b)(6) 2018, a 17mm master series valve was implanted in an infant patient with av canal defect.Due to thrombosis, the valve was explanted on (b)(6) 2018, and replaced with a second 17mm masters valve heart valve.On (b)(6) 2018, the second 17mm masters valve was explanted due to recurrent thrombosis.At that time, the patient received a melody transcatheter valve in the mitral position.The infant recovered and is maintained on lovanex and aspirin.Per report, the infant is discharged.

• Brand Name: SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• MDR Report Key: 7662747
• Report Number: 2648612-2018-00050
• Device Sequence Number: 11257695
• Product Code: LWQ
• UDI-Device Identifier: 05414734030496
• UDI-Public: 05414734030496
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2018

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: 04/18/2022
• Device Model Number: 17MHPJ-505
• Device Catalogue Number: 17MHPJ-505
• Device Lot Number: 5952878
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/08/2018
• Supplement Date Received by Manufacturer: 06/08/2018; 06/08/2018
• Initial Report FDA Received Date: 07/04/2018
• Supplement Report FDA Received Date: 08/22/2018; 09/20/2018
• 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: 9 MO