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 Codes	Material Separation (1562); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2020, a 17mm masters mechanical valve was selected for implant.During the procedure, the physician experienced difficulty repositioning the device after it was positioned, causing dislodgement of one of the leaflets.A replacement 15mm masters mechanical valve was implanted.The patient did not suffer any adverse health consequences.
Additional Manufacturer Narrative
An event of leaflet dislodgement was reported.Morphological investigation found that one leaflet had fractured, but was returned within the orifice.One recessed pivot area contained a chip.There was no evidence of material defect in the carbon coating that may have caused or contributed to the dislodged leaflets or orifice damage.Rather, the damage may have been caused by some external force applied to the valve which overstressed the carbon material.A review of the device history record showed the device met specifications prior to leaving abbott manufacturing facilities.The root cause of the event could not be definitively determined; however, the valve was replaced by a smaller, 15mm, valve which may have indicated oversizing.Per the instructions for use artmt100122073, "proper valve size selection is crucial.Do not oversize the valve.If the native annulus measurement falls between two sjm¿ masters series mechanical heart valve sizes, use the smaller size sjm¿ masters series mechanical heart valve.".

• 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: 10162642
• Report Number: 2648612-2020-00065
• Device Sequence Number: 2400204
• Product Code: LWQ
• UDI-Device Identifier: 05414734030496
• UDI-Public: 05414734030496
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/23/2024
• Device Model Number: 17MHPJ-505
• Device Catalogue Number: 17MHPJ-505
• Device Lot Number: 6918677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/11/2020
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 09/23/2020
• 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: Required Intervention
• Patient Age: 10 MO
• Patient Weight: 6