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

Device Problem Biocompatibility (2886)

Patient Problems Atrial Fibrillation (1729); Dyspnea (1816); Heart Failure (2206)

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The investigation results will be provided in a subsequent submission.

Event Description

On and unknown date a mechanical valve was implanted.The patient presented with symptoms of shortness of breath, atrial fibrillation, and clinical signs of heart failure.An echo indicated either pannus or thrombus.Patient was put on a heparin infusion.A later ct showed valve was moving well with some impingement - gradients no greater than 10 mmhg.The device is not to be explanted and the pannus / thrombus was deemed to be smaller on the later ct.Thrombus was not confirmed -could have been pannus or thrombus.The patient was reported to be in stable condition.

Manufacturer Narrative

An event of shortness of breath, clinical signs of heart failure, atrial fibrillation, and pannus or thrombus seen on echo 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.An initial review of complaints data was reviewed on 8 december 2020 as a component of the complaint handling risk review per wi 90591806.

• Brand Name: SJM MECHANICAL HEART VALVE (UNKNOWN)
• 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: 10771714
• MDR Text Key: 214159430
• Report Number: 2648612-2020-00110
• 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: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• 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: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization