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

Model Number 25A-101

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 08/18/2015

Event Type  Injury  

Event Description

Prosthetic aortic stenosis was noted with this 25 mm sjm mechanical heart valve implanted at an unknown date.At the time of surgery, the valve appeared normal; however it is reported the valve was explanted and subvalvular stenosis was debrided.

Manufacturer Narrative

(b)(4).The results of this investigation concluded there was focal fibrin thrombus on the sewing cuff, and both leaflets were fully mobile with no resistance occurring during manipulation.There was no evidence of acute inflammation and a gram stain was negative for organisms.No evidence was found to suggest the cause of the thrombus formation was due to an intrinsic defect in the valve, as supported by the analysis performed.The cause of the reported event remains unknown.

• Brand Name: SJM MECHANICAL HEART VALVE
• 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: 5111915
• MDR Text Key: 27052189
• Report Number: 2648612-2015-00025
• 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
• Type of Report: Followup
• Report Date: 08/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25A-101
• Device Catalogue Number: 25A-101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2015
• 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
• Patient Age: 65 YR