MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM MECHANICAL HEART VALVE (UNKNOWN); HEART-VALVE, MECHANICAL

Model Number 27MJ-501

Device Problems Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Mitral Regurgitation (1964); No Code Available (3191)

Event Date 09/22/2017

Event Type  Injury  

Manufacturer Narrative

Udi is unknown since the serial number is unknown.

Event Description

On an unknown date, a valve replacement procedure was performed and this mechanical heart valve (model and serial number unknown) was implanted.On (b)(6) 2017, this valve was explanted due to an unknown reason.Additional information has been requested.Patient identifier, age, weight and gender is not available.

Manufacturer Narrative

An event of mitral regurgitation was reported.Dried or coagulated blood in the seam between the leaflets and orifice initially immobilized the leaflets, but the leaflets regained mobility with limited mobility subsequent to forcefully opening the leaflets.No inflammation was found to be present in the sewing cuff.The cause of the reported event remains unknown.

Event Description

On an unknown date in 1995, initial mitral valve replacement (mvr) was performed and a carbomedics valve (sorin, size unknown) was implanted.On an unknown date in 2003, an aortic valve replacement (avr) was performed and a prosthetic valve (model and size unknown) was implanted.On an unknown date in (b)(6) 2006, a second mvr was performed due to regurgitation and the mitral valve implanted at the time of the initial surgical intervention was explanted and this mechanical heart valve (model and serial number unknown) was implanted.On (b)(6) 2017, a third mvr was performed due to mitral regurgitation (mr) and this valve was explanted.A 27 mm carpentier-edwards perimount mitral heart valve was then implanted.The patient¿s postoperative course has been uneventful.Per report, the patient has medical history of atrial fibrillation (af) and coagulopathy.However, there is no information available if warfarin was constantly administered or not.Patient weight and is not available.

• Brand Name: SJM MECHANICAL HEART VALVE (UNKNOWN)
• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7084169
• MDR Text Key: 93763922
• Report Number: 2648612-2017-00103
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2006
• Device Model Number: 27MJ-501
• Device Catalogue Number: 27MJ-501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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