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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 05/05/2021

Event Type  Injury  

Manufacturer Narrative

Investigation results will be provided in the final report.

Event Description

On (b)(6) 2005, a 21 mm mhv was successfully implanted in the aortic position.On (b)(6) 2021, the patient was hospitalized due to symptoms of heart failure.The patients international normalized ratio (inr) was a problem, so diuretic medication was administered to resolve the event.The patient was stable and was discharged (b)(6) 2021.The cardiologists has not made a decision on the therapy to follow yet as it is not clear to them whether the leaflets of the valve are opening maximally or not.This event is being conservatively reported due to a possible device issue which may contribution to that patients heart failure symptoms.

Manufacturer Narrative

Additional information: h2, h6, h10 an event of heart failure symptoms was reported.A more comprehensive assessment could not be performed as the device remains implanted was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: SJM MECHANICAL HEART VALVE
• 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: 11916723
• MDR Text Key: 253737801
• Report Number: 2648612-2021-00058
• Device Sequence Number: 1
• Product Code: LWQ
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR