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

Model Number	33MECJ-502
Medical Device Problem Codes	Gradient Increase (1270); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Mitral Regurgitation (1964); Heart Failure (2206)
Date of Event	10/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2014, a 33 mm masters series mechanical heart valve was implanted due to severe mitral stenosis and regurgitation.An echo performed on (b)(6) 2014 noted a well seated mitral valve with mild transvalvular regurgitation and suspicion of a small perivalvular leak at the septal edge.An echo performed on (b)(6) 2015, noted a well seated valve with normal function.An echo performed on (b)(6) 2018 noted a well seated valve; however, the mean gradient across the valve increased to 9 mmhg.There was mild mitral regurgitation.In the spring of 2018, the patient started to show symptoms of heart failure and mitral regurgitation was present.The patient's anticoagulation was increased but the patient continued to suffer from heart failure symptoms and the mitral regurgitation never went away.The patient never had endocarditis and the cause of the regurgitation was unknown but thought to be pannus overgrowth causing obstruction of one of the leaflets.The patient was also found to have moderate aortic stenosis and regurgitation.Due to the failing symptoms of the patient, on (b)(6) 2018, the patient was re-operated on to re-explore the 33 mm masters series mechanical heart valve and replace the aortic valve.During the explant procedure they noticed that one piece of one leaflet of the mechanical mitral valve was fractured/missing.The annulus itself was free of calcification.It is not known when the leaflet fractured as the patient did well for about three years after the implant procedure.The valve was explanted and replaced with a second 33 mm masters series mechanical heart valve.The fractured segment of leaflet was never recovered.The patient is reported to be stable and recovering and has been discharged.
Additional Manufacturer Narrative
An event of mitral regurgitation was reported.An event of a fractured leaflet was confirmed.Morphological and histopathological examination found one leaflet had fractured, however the fractured leaflet remained seated within the orifice.The intact leaflet was able to open and close completely.The sewing cuff was intact and contained a thin layer of fibrous pannus on both the inflow and outflow surfaces, however this did not impede leaflet mobility.No inflammations or calcifications were observed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.

• Brand Name: SJM MASTERS SERIES VALVE EXPANDED CUFF
• 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: 8017076
• Report Number: 2648612-2018-00088
• Device Sequence Number: 19131447
• Product Code: LWQ
• UDI-Device Identifier: 05414734006675
• UDI-Public: 05414734006675
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2019

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: 01/07/2018
• Device Model Number: 33MECJ-502
• Device Catalogue Number: 33MECJ-502
• Device Lot Number: 3904592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/09/2018
• Supplement Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 10/29/2018
• Supplement Report FDA Received Date: 01/02/2019
• 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; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 83