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

Model Number 19AGN-751

Device Problems Partial Blockage (1065); Gradient Increase (1270); Incomplete Coaptation (2507); Positioning Problem (3009)

Patient Problems Chest Pain (1776); Dyspnea (1816); Insufficiency, Valvular (1926)

Event Date 08/19/2014

Event Type  Injury  

Event Description

The information provided to sjm indicated a patient with this19mm regent mechanical valve recently presented to the emergency department with chest pain, dyspnea, and orthopnea.A transthoracic echocardiogram revealed prosthetic dysfunction with elevated gradients and moderate insufficiency.One leaflet appeared to be blocked and immobile.The valve was explanted and thrombus was reported on the immobile leaflet and in the recessed pivot region.

Manufacturer Narrative

(b)(4).Product evaluation summary: the results of this investigation concluded resistance was felt when manipulating one of the leaflets.The orifice contained a fracture with chips extending from it, multiple chips in the top and bottom rim, and scratches.A small amount of tissue was observed in one of the recessed pivot areas during initial observations; however, it is believed that it dislodged during transit to the pathologist.There were no visible thrombi or vegetations.There was no evidence of material defect in the carbon coating that may have caused or contributed to the orifice damage.Rather, the orifice damage was caused by some external force applied to the orifice which overstressed the carbon material.There was no evidence found to suggest the cause of the orifice damage and difficulty opening and closing one leaflet 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 orifice damage and difficulty opening and closing one leaflet remains unknown.

• Brand Name: SJM REGENT 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 ; 6517564470
• MDR Report Key: 4156371
• MDR Text Key: 4916851
• Report Number: 2648612-2014-00044
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: PP810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/06/2018
• Device Model Number: 19AGN-751
• Device Catalogue Number: 19AGN-751
• Device Lot Number: 4109620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2014
• Initial Date FDA Received: 10/09/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2013
• 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: 66 YR