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

Model Number 21A-101

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aortic Regurgitation (1716); Death (1802); Pulmonary Edema (2020); Low Cardiac Output (2501); Multiple Organ Failure (3261)

Event Date 12/22/2014

Event Type  Injury  

Manufacturer Narrative

The 21mm valve was returned to sjm for analysis and the device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with sjm specifications and procedures.There was no evidence found to suggest there was 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 23mm sjm mechanical heart valve was implanted in the mitral position and a 21mm sjm standard mechanical heart valve was implanted in the aortic position on (b)(6) 2014.Echo performed the following day documented the aortic and mitral valves were functioning normally.On (b)(6), the patient remained on a ventilator and developed pulmonary edema.Repeat echo performed at that time documented significant aortic regurgitation (ar).Tee documented both aortic leaflets were in the open position with "flickering" movement suggestive of severe ar.The patient required surgical exploration; at surgery, no evidence of thrombus or calcification was appreciated and there was normal leaflet motion on the arrested heart.The 21mm valve was explanted and a new 21mm sjm standard mechanical heart valve was implanted.Post-operatively, tee documented normal leaflet motion.The patient was in a low cardiac output, developed multi-organ failure and expired on (b)(6) 2014.

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. (CS); p.o. box 998; lot 20 b st.; caguas, puerto rico 0072 5
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC. (CS); 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: 4397791
• MDR Text Key: 13047204
• Report Number: 2648612-2015-00001
• 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: 12/23/2014

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: Physician
• Device Expiration Date: 06/30/2019
• Device Model Number: 21A-101
• Device Catalogue Number: 21A-101
• Device Lot Number: 4679658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2014
• Initial Date FDA Received: 01/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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): Death; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 80