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

Model Number 27MTJ-503

Device Problems Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tissue Damage (2104); Cardiac Perforation (2513)

Event Date 09/11/2018

Event Type  Injury  

Manufacturer Narrative

An event of a ruptured left ventricle was reported.The results of the investigation are inconclusive since the device was discarded by the hospital and therefore was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined; however, information from the field states that "the surgeon assumed that due to over sizing of this valve against the patient's mitral annulus, the patient's myocardium was likely perforated/torn by the pivot guard of this valve, which resulted in rupture of left ventricle.A smaller, 25mm, valve was subsequently implanted.

Event Description

On (b)(6) 2018, a mitral valve replacement (mvr) was performed and this 27mm masters series heart valve was implanted.Concomitantly, a tricuspid annuloplasty (tap) and maze procedure were performed.When returning to spontaneous circulation, the patient's left ventricle ruptured.The ruptured area of the left ventricle was repaired and this valve was explanted and replaced with a smaller 25mm masters series heart valve.The patient has been in stable condition postoperatively.The surgeon assumed that due to over sizing of this valve against the patient's mitral annulus, the patient's myocardium was likely perforated/torn by the pivot guard of this valve, which resulted in rupture of left ventricle.This valve was discarded in the hospital and will no longer be returned for analysis.No additional information is expected.

• Brand Name: SJM MASTERS SERIES HEART VALVE W/TEFLON CUFF
• 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: 7908238
• MDR Text Key: 121698457
• Report Number: 2648612-2018-00084
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734053624
• UDI-Public: 05414734053624
• 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: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2022
• Device Model Number: 27MTJ-503
• Device Catalogue Number: 27MTJ-503
• Device Lot Number: 6070688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2017
• 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: 68 YR