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

Model Number	21AFHPJ-505
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Endocarditis (1834)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
Reference manufacturer report number: 2648612-2020-00101.On (b)(6) 2016, a 27mm mechanical mitral valve and a 21mm mechanical aortic valve was implanted to replace an unknown tissue valve that was implanted in 2011.The patient has a history of endocarditis, systemic septic emboli, cardiomyopathy, hypertension, smoking, pulmonary hypertension, bicuspid aortic valve and moderate enlargement of ascending aorta.On (b)(6) 2020, it was reported that the patient may have endocarditis and that there is a planned intervention to replace the aortic valve due to stenosis.There is a possibility that the mitral valve will be replaced as well.
Additional Manufacturer Narrative
An event of stenosis was reported.A more comprehensive assessment could not be performed as the device remains implanted was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: SJM MASTERS SERIES FLEX CUFF HEMODYNAMIC PLUS
• 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: 10631745
• Report Number: 2648612-2020-00100
• Device Sequence Number: 3321340
• Product Code: LWQ
• UDI-Device Identifier: 05414734055246
• UDI-Public: 05414734055246
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2020

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: 05/08/2018
• Device Model Number: 21AFHPJ-505
• Device Catalogue Number: 21AFHPJ-505
• Device Lot Number: 4069374
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 10/05/2020
• Supplement Report FDA Received Date: 11/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 27MM MASTERS SERIES MECHANICAL HEART VALVE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Weight: 91