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

Model Number 31M-101

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 08/20/2015

Event Type  Injury  

Manufacturer Narrative

Gtin: unknown.

Event Description

A 31mm sjm mechanical heart valve was implanted in 1990.On (b)(6) 2015, the valve was explanted due to suspected endocarditis.Limited details were provided.

Manufacturer Narrative

The results of this investigation concluded both leaflets fully opened and closed without resistance.Pannus formation with calcifications and calcified focal organizing thrombus was found on the sewing cuff.There was no evidence of acute inflammation and gram stains were negative for organisms.No evidence was found to suggest the cause of the pannus, calcification, and thrombus formation was due to an intrinsic defect in the valve, as supported by review of the valve's device history record and the analysis performed.The cause of the reported event remains unknown.

Event Description

A 31mm sjm mechanical heart valve was implanted in 1990.On (b)(6) 2015, a tee documented vegetation on the mitral valve.On august 20, 2015 the valve was explanted secondary to a perivalvular leak with suspected endocarditis.During explant, the annulus was debrided of the vegetative material and pledgets.It was noted that the posterior mitral annulus and posterior leaflet were calcified.The 31mm valve was removed and a 29mm mechanical valve was implanted.The patient tolerated the procedure well and was taken to the icu in stable condition.The next day, the patient developed neurological changes consistent with an embolic stroke with hemorrhagic conversion.The fifth day post-explant, the patient was ambulating with assistance and was discharged in stable condition.

• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC. (CS); p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC. (CS); 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: 5086929
• MDR Text Key: 26146481
• Report Number: 2648612-2015-00023
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Report Date: 08/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 31M-101
• Device Catalogue Number: 31M-101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/1990
• 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): Required Intervention
• Patient Age: 57 YR