MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (CS-WOODRIDGE) SJM TISSUE HEART VALVE (UNKNOWN); HEART-VALVE, NON-ALLOGRAFT TISSUE

Device Problems Backflow (1064); Biocompatibility (2886)

Patient Problems Aortic Regurgitation (1716); Endocarditis (1834); Mitral Regurgitation (1964)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, complications from the valve implant included reoperation, stroke, bleeding, endocarditis, and structural valve deterioration.It was not reported what valve was implanted in these patients.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.All available information for conducting this investigation was collected and no additional follow-up attempts will not be needed.

Event Description

It was reported through a research article identifying st.Jude's mechanical mitral valves, mechanical aortic valves, and porcine valve (mitral valve) chosen for valve replacement surgeries.240 patients were in the study in which 59 of the devices were abbott valves.The patient has an average age of 19 years old, 136 of them being female.Details are listed in the article, titled, "contemporary outcomes of aortic and mitral valve surgery for rheumatic heart disease in sub-saharan africa".The devices may be related to adverse events related to serious injuries procedure such as, reoperation, stroke, major bleeding, endocarditis or structural valve deterioration.However, it is not indicated if any of these patients that had these serious injuries had an abbott valve implanted.

• Brand Name: SJM TISSUE HEART VALVE (UNKNOWN)
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (CS-WOODRIDGE); 177 east county road b; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC. (CS-WOODRIDGE); 177 east county road b; st. paul MN 55117
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10084467
• MDR Text Key: 193694052
• Report Number: 3007113487-2020-00012
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: ET
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/22/2020

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/28/2020
• Initial Date FDA Received: 05/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 19 YR