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

Model Number 31M-101

Device Problem Gradient Increase (1270)

Patient Problems Right Ventricular Dysfunction (2054); Thrombus (2101); Regurgitation, Valvular (2335)

Event Date 12/02/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).The results of this investigation concluded thrombus formation in the recessed pivot area, and both leaflets opened and closed with difficulty with incomplete closure of one of the leaflets.Special stains were negative for organisms, and no acute inflammation or significant calcifications were present.There was no evidence found to suggest the cause of the 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 fibrin and tears remains unknown.

Event Description

A 2d echocardiogram demonstrated a mechanical mitral valve with restricted opening, mild paravalvular regurgitation, elevated gradients, and significant right ventricular dysfunction.The mechanical valve was explanted and replaced with a smaller 27 mm sjm epic tissue valve.At the time of explant, thrombus was observed on the valve.The patient was reported to be stable postoperatively.

Manufacturer Narrative

(b)(4).

• Brand Name: SJM MECHANICAL HEART 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 0072 5
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 0072 5
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 4357997
• MDR Text Key: 13220821
• Report Number: 2648612-2014-00054
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2018
• Device Model Number: 31M-101
• Device Catalogue Number: 31M-101
• Device Lot Number: 4239666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2013
• 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: 23 YR
• Patient Weight: 37