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

Model Number 21AFHPJ-505

Device Problem Obstruction of Flow (2423)

Patient Problems Aortic Valve Stenosis (1717); Endocarditis (1834)

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event 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.

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
• 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: 10631745
• MDR Text Key: 209955336
• Report Number: 2648612-2020-00100
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734055246
• UDI-Public: 05414734055246
• 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,health
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 27MM MASTERS SERIES MECHANICAL HEART VALVE
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 91