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

Model Number 17MHPJ-505

Device Problems Material Separation (1562); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2020

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 195430658
• Report Number: 2648612-2020-00065
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734030496
• UDI-Public: 05414734030496
• Combination Product (y/n): N
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 10 MO
• Patient Weight: 6