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

Model Number	25AHPJ-505
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The 25mm masters valve was received in the product performance engineering lab within a shipping container.Upon initial receipt of the valve it was observed that one leaflet had been dislodged from the orifice and was returned.The valve rotated freely.The valve was grossly and microscopically examined.The sewing cuff was intact and contained blood/body fluids.The recessed pivot areas pivot guards, intact leaflet and dislodged leaflet did not contain any visible evidence of surface damage or anomalies.The orifice bottom rim had a small chip.It could not be conclusively determined how or when the damage occurred.The intact leaflet was properly inserted into the orifice and able to fully open and close with no resistance noted.The reported event of a dislodged leaflet was confirmed.One leaflet was dislodged from the orifice and returned with the valve.The bottom orifice rim contained a small chip.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.The cause of the leaflet dislodgment could not be conclusively determined.Please note, per the instructions for use artmt100045600 version a, "using the valve holder/rotator and an sjm valve holder handle, rotate the valve in situ to the desired position.The valve should rotate freely.If resistance is noted, the valve holder/ rotator may not be properly seated in the valve, the valve may not be in the fully closed position, or the valve may be oversized.If the valve does not rotate freely, do not force valve rotation.".
Event or Problem Description
On an (b)(6) 2019, a 25mm masters valve was selected for implant.While attempting to rotate the valve using the holder handle, a leaflet was dislodged from the device.The device was exchanged for a second 25mm master's valve (serial number: (b)(4)).There was a clinically significant delay to the procedure due to this event.No patient consequences were reported.

• 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: 8936675
• Report Number: 2648612-2019-00064
• Device Sequence Number: 2609345
• Product Code: LWQ
• UDI-Device Identifier: 05414734006293
• UDI-Public: 05414734006293
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Report Date (Section B): 08/27/2019

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: 09/05/2023
• Device Model Number: 25AHPJ-505
• Device Catalogue Number: 25AHPJ-505
• Device Lot Number: 6624467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2019
• Initial Report FDA Received Date: 08/27/2019
• 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
• Patient Age: 38 YR