FDA Adverse Event Malfunction Summary report: N

*

MDR report key: 3121656 · Received May 3, 2013

Report

Report Number
3121656
Event Type
Malfunction
Date Received
May 3, 2013
Date of Event
April 29, 2013
Report Date
May 3, 2013
Manufacturer
ST. JUDE MEDICAL, INC.
Product Code
LWQ
Product Problem
Yes
Report Source
User Facility report
Reporter Location
FL, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

AFTER MITRAL VALVE REPLACEMENT AND AORTIC VALVE REPLACEMENT, THE PATIENT WAS UNABLE TO SUSTAIN COMING OFF BYPASS WITH MULTIPLE ATTEMPTS. THE PATIENT'S BLOOD PRESSURE WOULD DROP IMMEDIATELY EACH TIME. AN INTRAOPERATIVE TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WAS PERFORMED AND C-ARM IMAGING. THE LEAFLETS WERE NOT OPENING PROPERLY. NOTES FROM THE OPERATIVE REPORT REGARDING THE ORIGINAL INSERTION OF THE AORTIC VALVE:(AORTIC)"VALVE WAS EXCISED AND SENT FOR PATHOLOGIC EXAMINATION. IT MAY BE NOTICED PATIENT'S BODY SURFACE AREA (BSA) WAS 1.4 IN A VERY SMALL AORTIC ROOT AND THE SINOTUBULAR JUNCTION. WE SIZED THE VALVE AND A 19MM ST. JUDE REGENT MECHANICAL VALVE ONE END THAT WAS THE CYLINDRICAL AND WOULD GO THROUGH THE ANNULUS AND THE REPLICA END WAS SITTING ON TOP OF THE ANNULUS, WHICH MADE IT APPROPRIATE SIZE. TWO SUTURES WERE PLACED CIRCUMFERENTIALLY AND ST. JUDE REGENT MECHANICAL VALVE WAS SECURED IN THE NATIVE ANNULUS WITH THE HELP OF SUTURES. IT SHOULD BE NOTICED TO INSERT THE VALVE WE HAD TO ENLARGE THE ROOT DOWN TOWARDS THE COMMISSURE WITH THE PERICARDIAL PATCH. THAT WAS DONE WITH TWO LAYERS OF RUNNING POLYPROPYLENE SUTURES. ONCE THE VALVE WAS THEN PLACED, THE AORTOTOMY WAS THEN CLOSED IN TWO LAYERS OF POLYPROPYLENE SUTURES."...(PATIENT THEN HAD DIFFICULTY IN COMING OFF BYPASS TWICE, SO THE SURGEON ORDERED FLUOROSCOPY)" THE AORTIC VALVE LEAFLETS WERE NOT OPENING COMPLETELY. ONCE THE FLUOROSCOPY DEMONSTRATED THAT WE DECIDED TO THE CROSS CLAMP AND REEVALUATE THE AORTIC VALVE...THE ST. JUDE REGENT MECHANICAL PROSTHESIS ON OBSERVATION HAD BOTH LEAFLETS OPENING WITHOUT ANY DIFFICULTY. THERE WAS NO TISSUE, WHICH WAS IMPINGING ON IT. AT THAT TIME, DECISION WAS MADE TO EXPLANT THE VALVE SINCE THERE WAS NO OBVIOUS DEFORMITY OR ABNORMALITY PREVENTING THE LEAFLET EXCURSIONS."..."THE PATIENT WAS WEANED WITHOUT ANY DIFFICULTY FROM BYPASS... POST BYPASS TEE DEMONSTRATED PRESERVED RIGHT AND LEFT VENTRICULAR FUNCTION AND NORMAL FUNCTIONING AORTIC AND MITRAL PROSTHESIS AND NO PARAVALVULAR LEAK...ONCE MAKING SURE THERE WAS ADEQUATE HEMOSTASIS MAINTAINED, THE STERNUM WAS RE-APPROXIMATED WITH STERNAL WIRES AND CHEST WALL CLOSED IN LAYERS. THE PATIENT TOLERATED PROCEDURE AND TRANSFERRED TO INTENSIVE CARE UNIT (ICU) IN STABLE CONDITION."THE FIRST MECHANICAL VALVE WAS REMOVED BECAUSE THE LEAFLETS WOULD NOT OPEN PROPERLY, AND SUBSEQUENTLY A SECOND DEVICE WAS USED WHICH DID WORK PROPERLY.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?STERNOTOMY, MITRAL VALVE REPLACEMENT, AORTIC VALVE REPLACEMENT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
195147 * HEART-VALVE, MECHANICAL LWQ ST. JUDE MEDICAL, INC. 19AGFN-756 *

Patients

Seq Age Sex Outcome Treatment
1 49 YR