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

Model Number	15MHPJ-505
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2017, a 15mm masters valve was selected for implant in the mitral position as part of the us clinical study.On (b)(6) 2019, (b)(4) clinical affairs was informed that the device was explanted.Additional information has been requested.(b)(4).
Additional Manufacturer Narrative
The valve was explanted following stenosis and regurgitation.Both leaflets opened and closed completely and easily.Fibrous pannus ingrowth was noted on the inflow and outflow surfaces, but was predominantly limited to the sewing cuff with focal areas extending onto the valve orifice.This pannus did not reach into the inner diameter of the valve.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product was confirmed to have met all defined manufacturing specifications at the time of release to commercialization.Though the cause of the reported event could not be conclusively determined, information from the field indicated that echocardiogram findings determined the patient had outgrown the device.This is consistent with the findings of pannus, as the increased interaction between the device and patient could have been a contributing factor.
Event or Problem Description
On (b)(6) 2017, a 15mm masters valve was selected for implant in the mitral position as part of the us clinical study.On (b)(6) 2019, abbott clinical affairs was informed that the device was explanted.The patient's clinical records were received and identified the patient, a toddler with complex medical history consisting of: shone syndrome, pulmonary hypertension, failure to thrive, lv hypertrophy.Past surgical history includes: mitral valve repair (2016), multiple aortic balloon valvuloplasties, mvr (15mm mitral valve), sub-aortic resection, and resection of left ventricular fibrosis and muscle bundles.The echocardiogram findings determined the gradient across the implanted mitral valve was due to the somatic growth of the subject; there was no alleged deficiency with the masters valve.The valve was explanted on (b)(6) 2018, and successfully replaced with a 19mm masters valve.The patient remained hemodynamically stable throughout the procedure.(ec0000-681-022, halo: us-3902).

• 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: 8267706
• Report Number: 3007113487-2019-00003
• Device Sequence Number: 14046039
• Product Code: LWQ
• UDI-Device Identifier: 05415067016522
• UDI-Public: 05415067016522
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/05/2019

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: 3698001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/02/2019
• Supplement Date Received by Manufacturer: 02/01/2019; 03/15/2019
• Initial Report FDA Received Date: 01/22/2019
• Supplement Report FDA Received Date: 02/20/2019; 04/05/2019
• 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: Required Intervention