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

Model Number	29MECJ-502
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Mitral Valve Stenosis (1965); Thrombus (2101)
Date of Event	11/07/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, a patient with barlow¿s disease underwent a redo mvr due to leakage.The original mitral valve prosthesis was explanted and a 29mm masters valve was implanted in the mitral position.On post-operative day 1, the patient had coronary stent thrombosis, and the physician elected to do a circumflex coronary bypass.Heparin was also administered, and after three days on anticoagulants, the patient ¿s inr was out of range.On (b)(6) 2018, increased mitral gradient was observed, and a scan revealed mitral thrombosis.On (b)(6) 2018, the masters valve was explanted and replaced with a 29mm edwards perimount valve.Upon explant, no endocarditis was reported.The patient was reported to be recovering.
Event or Problem Description
On (b)(6) 2018, a patient with barlow¿s disease underwent a redo mvr due to leakage.The original mitral valve prosthesis was explanted and a 29mm masters valve was implanted in the mitral position.On post-operative day 1, the patient had coronary stent thrombosis confirmed on echocardiogram, radio imaging and ct scan, and the physician elected to do a circumflex coronary bypass.Heparin was also administered, and after three days on anticoagulants, the patient ¿s inr was initially too low, then it increased and was too high.On (b)(6) 2018, increased mitral gradient was observed, and a scan revealed mitral thrombosis.On (b)(6) 2018, the masters valve was explanted and replaced with a 29mm edwards perimount valve.Upon explant, no endocarditis was reported.The patient was reported to be recovering.
Additional Manufacturer Narrative
An event of explant due to increased gradient and thrombosis was reported.Morphological and histopathological examination revealed the leaflets opened and closed completely and easily.Non-adherent clots were found throughout the mechanical leaflets and pivot recesses, which contained fungal hyphae.It is unknown if the fungal hyphae represented true infection or were a contaminant, as no infection was reported from the field.No inflammation or significant calcifications were found.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported thrombosis remains unknown.Information from the field indicated that the patient had a medical history of barlow's disease, and after the operation, the physician elected to do a circumflex coronary bypass, and heparin was administered, after three days of which the patient's inr went from too low to too high.

• 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: 8131271
• Report Number: 2648612-2018-00104
• Device Sequence Number: 19275221
• Product Code: LWQ
• UDI-Device Identifier: 05414734006545
• UDI-Public: 05414734006545
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/20/2019

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: 07/15/2023
• Device Model Number: 29MECJ-502
• Device Catalogue Number: 29MECJ-502
• Device Lot Number: 6543828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/08/2018
• Supplement Date Received by Manufacturer: 12/05/2018; 01/21/2019
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 12/23/2018; 02/20/2019
• 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: 58 YR