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

Device Problem Calcified (1077)

Patient Problem Pulmonary Edema (2020)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, a mechanical valve was replaced due to prosthesis-patient mismatch.Calcification of the annulus as well as pulmonary edema, pulmonary hypertension, and pneumonia after surgery, was also reported.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

In an article titled "manouguian dvr for ppm of post-mitral valve replacement" the following was reported: due to incomplete atrioventricular septal defect (iavsd), iavsd endocardial repair had been performed at 1 month.Plus mitral valvuloplasty at 1 year and mitral valve replacements with sjm mechanical valve at 2 and 7 years had been performed.Preoperative examination revealed calcification of the annulus.Dvr was performed this time.The aortic valve was replaced with sjm regent mechanical valve(21mm) and sjm mechanical valve in the mitral position was replaced with non-abbott mechanical valve(25mm) due to patient prosthesis mismatch.After surgery, pulmonary edema, pulmonary hypertension, and pneumonia were observed, but the patient recovered and discharged.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9014074
• MDR Text Key: 160442961
• Report Number: 2648612-2019-00075
• 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: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/16/2019
• 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): Required Intervention
• Patient Age: 33 YR