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

Model Number CVD0040

Device Problem Perivalvular Leak (1457)

Patient Problem Dyspnea (1816)

Event Date 11/28/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the serial number was unavailable.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

On an unknown date in 2012, a sjm mechanical valve (details unknown) was implanted in the aortic position.In (b)(6) 2016, the patient presented with dyspnea, anemia and heart-failure symptoms.A tee performed on (b)(6) 2016 revealed a pvl.On (b)(6) 2016, a 4/4 amplatzer duct occluder ii (adoii) was attempted to close the crescent-shaped pvl; however, the adoii was found to be not suitable for closure due to sizing/patient anatomy.Without releasing the adoii, the device was removed.The pvl was successfully closed using two 6 mm amplatzer vascular plug 2 devices.Efforts to obtain further information or to verify the model/manufacturer of the mechanical valve implanted in 2012 were unsuccessful.

• 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 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: 6187094
• MDR Text Key: 62765168
• Report Number: 2648612-2016-00125
• 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: Initial
• Report Date: 11/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CVD0040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 60 YR
• Patient Weight: 74