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

Device Problem Backflow (1064)

Patient Problems Mitral Regurgitation (1964); Valvular Stenosis (2697)

Event Date 09/28/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2009, the patient had a mechanical mitral 23 mm valve.On an unknown date, severe mr/prosthetic stenosis was discovered.On (b)(6) 2020 the patient underwent an explant of the valve.A medtronic mosaic 27 mm was chosen as the replacement valve.

Manufacturer Narrative

This event was reported in error.Additional information was received that confirmed this device and this event did not involve an abbott device.Please disregard.

• 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: 10685487
• MDR Text Key: 211534155
• Report Number: 2648612-2020-00102
• 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,health
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• 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: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 65 YR