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

Model Number 21MJ-501

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Mitral Valve Stenosis (1965); Pleural Effusion (2010); Cardiac Perforation (2513); Heart Failure/Congestive Heart Failure (4446)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, pannus was found on an implanted mechanical valve which was causing mitral stenosis.The valves was explanted and after the explant procedure a rupture in the muscular part of the interventricular septum was found, which was surgically repaired.Pleural effusion, hipoalbuminemia, and wound infection was also reported.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

The article, "ventricular septal rupture after mechanical mitral valve replacement," was reviewed.This article presented a case study of a (b)(6) female patient with congenital partial atrioventricular septal defect and parachute mitral valve.The patient underwent surgical closure of the atrial septal defect with an autologic pericardial patch in 2002, this was followed by a 21mm (b)(6) mechanical mitral valve replacement due to severe mitral incompetence in 2004.The patient was admitted into the hospital with heart failure symptoms, (b)(6) heart association ((b)(6)) class iii.Echocardiographic examination revealed pannus-related mechanical prosthesis dysfunction causing severe mitral stenosis.The patient was referred for mitral valve replacement.The early post-operative period after a 25 mm (b)(6) medical regent valve replacement was uneventful.During the third post-operative day, the patient presented with progressive dyspnea and hypotension requiring catecholamine infusion.A right pleural effusion was diagnosed and drained, but recurrent pleural effusions developed.The physical examination revealed a loud holosystolic murmur at the left sternal border with a thrill.Transthoracic echocardiography showed a rupture in the muscular part of interventricular septum with two left-to-right shunts considered significant.A cardiac computed tomography confirmed the diagnosis the patient was referred to redo operation.Ventricular septal rupture closure using pericardial patch followed by a tricuspid valvuloplasty with a 26 mm edwards ring were performed.In the early post-operative period, the patient required another pleural drainage.Laboratory results showed hipoalbuminemia, which was treated with intravenous albumins supplementation.Moreover, pseudomonas aeruginosa wound infection was diagnosed.As targeted antibiotic therapy was ineffective, negative pressure wound therapy was implemented.All the applied treatment methods resulted in gradual improvement in the patient¿s condition.Eventually, she was discharged from the hospital, and after a 3-month follow-up period, remained free of heart failure symptoms.No additional information was provided.[the primary and corresponding author of the article is (b)(6), md, phd, department of (b)(6) heart disease, (b)(6) institute of cardiology, (b)(6), with email address of (b)(6).Patient's information (e.G.Age, weight, gender, ethnicity, race, patient's initials) cannot be handled by abbott in absence of patient's written consent as required by the personal data protection national legislation.National legislation prevents the recording of such information.A written consent has not been obtained in this case; therefore, this information is not available.

• Brand Name: SJM MASTERS SERIES MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, LLC; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725 ; * 00725
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, LLC; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13595479
• MDR Text Key: 286742903
• Report Number: 3005334138-2022-00166
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21MJ-501
• Device Catalogue Number: 21MJ-501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2022
• 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: 18 YR
• Patient Sex: Female