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

Model Number 21MJ-501

Device Problem Obstruction of Flow (2423)

Patient Problems Pulmonary Valve Stenosis (2024); Heart Failure (2206)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, a mechanical valve was explanted due to pulmonary valve prothesis dysfunction and pulmonary stenosis.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 "a case of complete fifth surgery with title: systemic hyperkalemia and start of cardiopulmonary artificial surgery prior to sternotomy" was reviewed.This research article is a case study (b)(6)-year-old man with a history of multiple (four times) surgery for tetralogy of fallot.The patient had severe lymphedema, congestive ulceration, and scrotal edema were observed in both lower legs.The patient had a 21mm masters valve implanted.The patient had progressive right heart failure due to pulmonary valve prosthesis dysfunction and pulmonary stenosis.A cardiopulmonary bypass was started before the sternotomy due to adhesions below the sternum were suspected to be high due to history of multiple past surgeries, and that the aorta was damaged during a previous surgery.The sternum was dissected after initiating extracorporeal circulation with right atrial prolapse via the right internal vein and left subclavian artery and despite the aortic damaged, a re-rastelli operation was completed using a 25mm masters valve under hypothermic ventricular fibrillation combined with systemic hyperkalemia and without causing deterioration of circulatory dynamics.42 days after the surgery, the patient was transferred to the hospital for rehabilitation during which the patient was able to take oral intake during gait practice.Three months post transfer, the patient died of multiple organ failure due to sepsis caused by cellulitis of the lower leg.There was no allegation that the death was due to the master valve implanted.The primary author of the article is daita kobayashi md of steel memorial muroran hospital.

• Brand Name: SJM MASTERS SERIES 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: 10569727
• MDR Text Key: 208088069
• Report Number: 2648612-2020-00094
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model 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: 08/25/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 41 YR