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

Model Number 23AJ-501

Device Problem Obstruction of Flow (2423)

Patient Problems Dyspnea (1816); Pulmonary Edema (2020); Stenosis (2263)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, a 23 mm mechanical valve was replaced with a 25 mm valve due to stenosis caused by patient-prosthesis mismatch.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.

Event Description

As reported in a research article, on an unknown date, a 23 mm mechanical valve implanted when the patient was (b)(6) was replaced with another 23 mm mechanical heart valve due to hemolysis caused by residual regurgitation.However, the 23 mm valve was replaced with a 25 mm regent mechanical valve at (b)(6) due to stenosis and acute pulmonary edema caused by patient-prosthesis mismatch.The replacement procedure was successfully completed; the patient was reported to be stable and is being monitored as an out ¿ patient.Additional information could not be obtained.Manufacturer report number: 3003681312-2020-00003.

• Brand Name: 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 ; RQ 00725
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725 ; RQ 00725
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9741484
• MDR Text Key: 192646940
• Report Number: 3003681312-2020-00004
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 23AJ-501
• Device Catalogue Number: 23AJ-501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2020
• 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): Other; Required Intervention
• Patient Age: 35 YR