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 Perivalvular Leak (1457); Obstruction of Flow (2423)

Patient Problems Corneal Pannus (1447); Thrombosis (2100); Stenosis (2263)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, 11 out of 17 patients had the mechanical valve replaced due to either obstruction of flow, thrombus, paravalular leak, pannus formation, or stenosis after an average of 2.9 years.The majority of patients were implanted with a larger valve.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

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).11 patients underwent prosthesis replacement, with a median time to prosthetic replacement of 2.9 years.The replacement valves were size 15mm (1), 17mm 92), 21mm (2), and 23mm (1).The main indication for replacement was obstruction of flow, thrombosis, paravalvular leak, pannus formation, and stenosis.

Manufacturer Narrative

As reported in a research article, our of 61 patients 32 had adverse events after mechanical valve implant including ventilator support, reoperation, renal failure, bleeding, cardiac arrest, being placed on ecmo and paralysis.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

It was reported through a research article identifying 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." both articles were part of the same study that analyzed the same data.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).It was reported that there was 61 patient with 31 of them male, a median age of 5.9 months and a median weight of 5.7 kg.The main indication for replacement was obstruction of flow, thrombosis, paravalvular leak, pannus formation, and stenosis.

• 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: 9717181
• MDR Text Key: 189709461
• Report Number: 2648612-2020-00018
• 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: 11/11/2020

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): Other; Required Intervention
• Patient Age: 6 MO
• Patient Weight: 6