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

Model Number 15MHPJ-505

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Renal Failure (2041); Discharge (2225); Complete Heart Block (2627)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, eight patient experienced adverse events after mitral valve implant, including pacemaker implantation, reoperations, renal failure, bleeding and mediastinitis.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

Reference manufacturing report 2648612-2020-00018.It was reported through a research article identifying 15mm masters valve that may be related to surgical intervention post procedure.Details are listed in the article, titled "mitral valve replacement with the 15-mm mechanical valve: a 20-year multi-center experience." it was reported in the article that 17 patients received 18 mitral valve replacement using the 15-mm masters valve.9 of the patient were female and 8 of the patients were male.The average age of the patient pool was 3.2 months (1.2 - 5.6 months) and the weight is 5.2 kg (3.9 kg - 5.7 kg).8 patients experienced major adverse event including: permanent pacemaker implantation (3), reoperation prior to discharge (2), renal failure requiring dialysis (2), cardiac arrest requiring resuscitation (2), bleeding requiring reoperation (2), mediastinitis requiring reoperation (1).

Event Description

It was reported through a research article identifying 15mm masters valve that may be related to surgical intervention post procedure.Details are listed in the article, titled "mitral valve replacement with the 15-mm mechanical valve: a 20-year multi-center experience." and "mechanical mitral valve replacement: a multicenter study of outcomes with use of 15-17mm prostheses".This research article is a retrospective multicenter experience to evaluate early and mid-term outcomes (mortality and prosthetic valve intervention) after mitral valve replacement (mvr) with 15-17mm mechanical prostheses.Mvr was performed in 61 infants with abbott, carbomedics, and sorin mechanical valves.There is no allegation of malfunction of the mechanical valves.The article concluded that mitral valve replacement with a 15-17mmm mechanical prostheses is an important alternative to save critically ill neonates and infants in whom the mitral valve cannot be repaired.Prosthesis replacement for outgrowth can be carried out with low risk.The primary author of the article is rinske j.Ijsselhof, md of university medical center utrecht, department of pediatric cardiac surgery, with the corresponding email: (b)(6).Major adverse event without reoperation includes: permanent pacemaker implantation, reoperation prior to discharge, renal failure requiring dialysis, cardiac arrest requiring resuscitation, bleeding requiring reoperation, mediastinitis requiring reoperation.

Manufacturer Narrative

As reported in a research article, nine patients had a pacemaker implanted after mechanical valve implant.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.

• Brand Name: SJM MASTERS SERIES HEMODYNAMIC PLUS 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
• MDR Report Key: 9717192
• MDR Text Key: 189710129
• Report Number: 2648612-2020-00019
• 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: foreign,health professional,l
• Type of Report: Initial,Followup,Followup
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 15MHPJ-505
• Device Catalogue Number: 15MHPJ-505
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 MO
• Patient Weight: 6