FDA Adverse Event Death Summary report: N

AMPLAZTER SEPTAL OCCLUDER

MDR report key: 698785 · Received April 5, 2006

Report

Report Number
2135147-2006-00025
Event Type
Death
Date Received
April 5, 2006
Date of Event
March 3, 2006
Manufacturer
AGA MEDICAL CORP.
Product Code
MLV
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
OH, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

IN THE COURSE OF A WORK-UP OF TRANSIENT-LIKE SYMPTOMS, THE PATIENT WAS NOTED TO HAVE A SECUNDUM ATRAIL SEPTAL DEFECT WITH RV VOLUME OVERLOAD PATTERN. SHE HAD UNEXPLAINED WEAKNESS OF ONE OF HER UPPER EXTREMITIES THAT RESOLVED SPONSTANEOUSLY ADN LATER HAD LOWER EXTREMELY EDEMA FOR UNKNOWN CAUSE. ECHOCARDIOGRAM DEMONSTRATED THE ASD WITH RV VOLUME OVERLOAD AND CALCULATED QP/QS RATIO OF 1.8/1 ALONG WITH MRI STUDY. IT SHOULD NOTED THE RV EJECTION FRACTION AT ONE POINT WAS DECREASED AT 33%. A LEFT ATRIAL ANGIOGRAM WAS PERFORMED, DEMONSTRATING A MODERATE SIZE SECONDUM ATRAIL SEPTAL DEFECT WITH LEFT-TO-RIGHT SHUNTING. INTRACARDIAC ECHO WAS PERFORMED AND DEMONSTRATED RV ENLARGEMENT. THERE WAS A SECUNDUM ATRIAL SEPTAL DEFECT WITH VERY THIN, REDUNDANT AND FLOPPY SEPTUM PRIMUM TISSUE. THE DEFECT MEASURED ANYWHERE FROM 10-17 MM IN DIAMETER DEPENDING ON THE CARDIAC CYCLE. THERE WAS MILDLY DEFICIENT RETROAORTIC RIM. AFTER 1 GM ANCEF WAS WAS ADMINISTERED INTRAVENOUSLY, A 25 MM X 3 CM LONG NUMED BALLOON SIZING CATHTER WAS PLACED OVER THE AGA GUIDEWIRE AND THE BALLOON STRETCH DIAMETER WAS MEASURED TO BE 19.2 MM. A 20 MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN BECAUSE OF THE DEFICIENT RETROAORTIC RIM AND WAS LOADED ON THE DELIVERY CABLE IN THE USUAL MANNER. A 10 MM COOK HUSDORF LONG SHEATH AND DILATOR WAS PREPPED, PURGED AND PASSED OVER THE GUIDEWIRE INTO THE LEFT ATRIUM. THE DEVICE WAS DELIVERED UNDER ICE GUIDANCE WITHOUT DIFFICULTY. THE DEVICE WAS WELL SEATED AND DID NOT IMPINGE ON AV VALVES OR PULMONARY VENOUS FLOW. IT WAS, THEREFORE, RELEASED AND FOLLOW-UP INTRACARDIAC ECHOCARDIOGRAPHY DEMONSTRATED THE DEVICE TO BE IN EXCELLENT POSITION WITHOUT ANY SIGNIFICANT FLOW EXCEPT FOR ON LEVO PHASE, THERE WAS FLOW THROUGH THE DEVICE AS TO BE EXPECTED. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE AND THE PATIENT WAS TRANSFERRED TO PACU IN STABLE CONDITION. IN 06, THE PATIENT DEVELOPED SEVERE CHEST PAIN AND SHORTNESS 0F BREATH. WHILE BREATH. WHILE BEING TRANSPORTED TO THE HOSPITAL BY THE SQUAD, SHE DEVELOPED CARDIAC ARREST. SHE ARRIVED AT THE LOCAL EMERGENCY DEPARTMENT AT 18:32 AND SHE EXPIRED AT 19:54. HER HUSBAND INDICATED THAT SHE HAD VAGUE CHEST PAIN OVER THE SUBSEQUENT SEVERAL WEEKS. THE PAIN SUBSIZED UNTIL A FEW DAYS PRIOR TO DEATH WHEN SHE DEVELOPED RECURRENCE OF THE PAIN. AUTOPSY FINDING: ATRIAL SEPTAL DEFECT, FOSSA OVALIS TYPE, STATUS POST TRANSCATHTER CLOSURE. EROSION, ANTERIOR ATRIAL WALL BY THE RIGHT AND LEFT SIDES OF THE SEPTAL DEFECT OCCLUDER. EROSION WITH PERORATION, AORTIC SINUS OF VALSAVA (NONCORONARY CUSP) AT THE CONTACT SITE WITH ANTERIOR ATRIAL WALL EROSION. HEMOPERICARDIUM 300 ML. ADDITIONAL CONGENITAL CARDIOVASCULAR ANOMALIES. ATRIAL SEPTAL DEFECT, SINUS VENOSUS TYPE. ANOMALOUS PULMONARY VENOUS RETURN, RIGHT, UPPER AND MIDDLE PULMONARY LOBES TO SUPERIOR VENA CAVA. SEROSANGUINEOUS EFFUSIONS, PERITONEUM (50 ML), RIGHT PLEURA (130 ML), AND LEFT PLEURA (75 ML). AT AUTOPSY THERE WAS 300 ML OF BLOOD IN THE PERCARDIUM. THE BLOOD HAD DISSECTED ALONG THE GREAT VESSELS SUPERIORLY INTO THE MEDIASTINAL SOFT TISSUE AROUND THE AORTIC ARCH. THE ATRIAL SEPTAL DEFECT OCCLUDER APPEARED INTACT FROM THE RIGHT AND LEFT SIDES OF THE ATRIAL SEPTUM. ON THE EXTERNAL SURFACE OF THE HEART, THERE WERE TWO PARALLEL RIDGES THAT PROTRUDED OUTWARD FROM THE ANTERIOR WALL OF THE ATRIUM SEPTUM. THESE RIDGES WERE FORMED FROM PRESSURE FROM THE RIGHT AND LEFT SIDES OF THR OCCLUDER. BOTH RIDGES HAD LINEAR EROSIONS MEASURING 1.5 X 0.3 CM. WITH EXPOSED METALLIC SURFACE OF THE OCCLUDER. THE POSTERIOR WALL OF THE AORTIC ROOT HAD A 1.8 X 0.8 CM. THICKENED AREA OF ADVENTITIA WITH A CENTRAL, LINEAR 1.1 X 0.2 CM. EROSION. A 1.5 MM DIAMETER PROBE EASILY PASSED THROUGH THE EROSION INTO THE SINUS OF VALSALVA BEHIND THE NONCORONARY CUSP OF THE AORTIC VALVE. THIS PERFORATION SITE WAS ANATOMICALLY RELATED TO THE EROSION SITE OF THE ATRIAL SEPTAL DEFECT OCCLUDER. ADDITIONAL FINDINGS INCLUDED A SINUS VENOUS TYPE ATRIAL SEPTAL DEFECT AND PARTIAL ANOMALOUS PULMONARY VENOUS RETURN FROM THE UPPER AND MIDDLE RIGHT PULMONARY LOBES TO THE SUPERIOR VENA CAVA. THE UNDERLYING CAUSE OF THE DEATH WAS ATRIAL SEPTAL DEFECT (FOSSA OVALIS TYPE ). THE INTERMEDIATE CAUSE WAS PERFORATION OF THE AORTA AND THE IMMEDIATE CAUSE WAS HEMOPERICARDIUM.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 AMPLAZTER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORP. 9-ASD-020 M05F15-08

Patients

Seq Age Sex Outcome Treatment
1 41 YR Death