FDA Adverse Event Summary report: N

MITRAL PROSTHETIC HEART VALVE

MDR report key: 1884254 · Received October 18, 2010

Report

Report Number
1884254
Date Received
October 18, 2010
Date of Event
September 27, 2010
Report Date
October 18, 2010
Manufacturer
ATS MEDICAL INC.
Product Code
LWR
Report Source
User Facility report
Reporter Location
MT, US

Narratives

Description of Event or Problem · 1

A YOUNG MALE PRESENTED TO ED W/SEVERE PALPITATIONS AND CHEST PAIN; TEE REVEALED SEVERE MITRAL REGURGITATION WITH DILATED (L) VENTRICLE & (L)ATRIUM. TO OR FOR MITRAL VALVE REPLACEMENT MAZE PROCEDURE (BECUASE OF THE DILATED LEFT ATRIUM AS WELL AS PALPITATIONS) AND CARDIAC EVENT MONITOR IN CASE PT CONTINUES TO HAVE PALPITATION SYMPTOMS POST-OPERATION. THE FIRST MECHANICAL PROSTHESIS PUT IN DID NOT FUNCTION CORRECTLY AS ONE OF THE LEAFLETS WOULD NOT CLOSE AND PATIENT WAS LEFT WITH SEVERE MITRAL REGURGITATION. THIS NECESSITATED CROSSCLAMPING AND REPLACING WITH ANOTHER MECHANICAL VALVE THAT FUNCTIONED PROPERLY, TOTAL AORTIC CROSSCLAMP TIME WAS 148 MINUTES. CARDIOPULMONARY BYPASS TIME WAS 207 MINUTES.====================== HEALTH PROFESSIONAL'S IMPRESSION======================PATIENT'S LEAFLETS WERE EXCISED, TAKING CARE TO PRESERVE MOST OF THE SECONDARY AND TERTIARY CHORDAE. PLEDGETED MATTRESS SUTURES OF 2-0 ETHIBOND PLACED AROUND MITRAL ANNULUS W/PLEDGETS ON THE (L) ATRIAL SIDE. ANULUS SIZED FOR 31 MM MECHANICAL PROSTHESIS, AN EASY FIT, SUTURES PLACED THROUGH THE SEWING RING OF THE PROSTHESIS AND LOWERED ONTO THE ANNULUS. MEDTRONIC RADIOFREQUENCY PEN TO CREATE MAZE LESION SET, INCLUDING BILATERAL PULMONARY VEIN ISOLATION CROSSING LESIONS BETWEEN THESE TWO AND ANOTHER LESION FROM THE BOX LESIONS ACROSS THE ISTHUMS TO THE THE MITRAL ANNULUS. DE-AIRING MANEOUVERS W/CROSSCLAMP...PT HEAD-DOWN POSITION, AORTIC ROOT VENT ON, HEART FULL AND LUNGS PUMPING. EMPTIED HEART OF VOLUME AND W/FULL SUCTION OF THE AORTIC ROOT VENT, REMOVED AORTIC CROSSCLAMP. HEART WAS ELECTROCARDIOVERTED. (R)ATRIAL PACING BUTTON AND (R) VENTRICULAR PACING WIRE PLACED, BEGAN VENTILATING, WEANED PATIENT DOWN ON CARDIOPULMONARY BYPASS TO MINIMAL FLOW. TEE REVEALED STILL SIGNIFICANT MITRAL REGURG, APPEARED THAT ONE OF THE LEAFLETS WAS NOT CLOSING PROPERLY; CLOSSCLAMPED AS BEFORE AND OPENED THE PREVIOUS (L) ATRIOTOMY. VALVE WAS INSPECTED AND NO SIGNIFICANT ABNORMALITY COULD BE FOUND, AT LEAST TO MANUAL DISTRACTION IT SEEMED TO OPEN AND CLOSE APPROPRIATELY, HOWEVER, IT WAS DECIDED TO REMOVE AND PLACE NEW VALVE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MITRAL PROSTHETIC HEART VALVE HEART VALVE, NON-ALLOGRAFT TISSUE LWR ATS MEDICAL INC. 500DM31 31MM ANNULUS SIZE

Patients

Seq Age Sex Outcome Treatment
1 22 YR NONE NOTED FROM PATIENT'S CHART.