MAUDE Adverse Event Report: UNKNOWN MECHANICAL HEART VALVES; HEART-VALVE, MECHANICAL

Patient Problem Thrombosis/Thrombus (4440)

Event Date 01/15/2024

Event Type  Injury  

Event Description

Had clots on mechanical heart valves.Life threatening and had to be hospitalized.Please contact (b)(6) clinic in (b)(6) for the details.Reference report: mw5153610.

• Brand Name: MECHANICAL HEART VALVES
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 19059259
• MDR Text Key: 339701410
• Report Number: MW5153611
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: 2 PM WARFARIN 3 MG TAB 1 DAILY (VARIES) / 1 MG TAB 1 DAILY (VARIES).; ATORVASTATIN 20 MG TAB 1 DAILY. ; CORLANOR 5 MG 1 TAB DAILY. ; ENTRESTO 24MG/26MG (2 TABS DAILY). ; ESCITALOPRAM 20 MG TAB 1 DAILY. ; FARXIGA / DAPAGLIFLOZIN 5MG DAILY (DIABETES MED).; LEVOTHYROXINE 100 MCG TAB 1 DAILY. ; METFORMIN 500 MG TAB 1 DAILY.; METOPROLOL SUCCINATE 50 MG TAB 1 DAILY (BETA BLOCK). ; MULTIVITAMIN.; PACEMAKER.; PANTOPRAZOLE 40 MG CAP 1 DAILY. ; STIOLTO INHALER OLODATEROL 2AM.; TOPIRAMATE 50 MG TAB 1AM.; XEMBIFY.
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White