Description of Event or Problem · 1
IN 2002, PT WAS DISCOVERED TO HAVE A LONG-STANDING HEART PROBLEM WITH WHICH SHE WAS BORN. SHE HAD A SMALL HOLE IN THE HEART KNOWN AS A PATENT FORAMEN OVALE OR PFO. THIS IS A SMALL HOLE IN THE HEART WHICH EXISTS IN UP TO 25% OF ALL AMERICANS. A FREQUENTLY USED TREATMENT FOR THIS CONDITION IS MONITORING AND BLOOD THINNERS. PT WAS MONITORED BY A FAMILY PHYSICIAN WHO ALSO PRESCRIBED BLOOD THINNER FROM THE TIME PT FIRST LEARNED, SHE HAD THIS HEART PROBLEM. WHEN PT SHOWED SOME SIGNS OF DIZZINESS IN THE SPRING OF 2005, PT'S FAMILY PHYSICIAN RECOMMENDED, SHE SEE A CARDIOLOGIST. DR (CARGIOLOGIST) SENT HER TO SEE ANOTHER CARDIOLOGIST. HE EXAMINED PT IN 2005. DR (SECOND) WITH SIGNIFICANT EXPERIENCE IN DEVICES WHICH CLOSE THE SMALL HEART HOLE IN PATIENTS LIKE HER. BASED ON HIS SUGGESTION FROM A (DURING THE SAME YEAR) VISIT, PT ENTERED HOSP FOR AN OPERATION ON THE HEART KNOWN AS AN AMPLATZER PFO CLOSURE WHICH WOULD RESULT IN THE PLACEMENT OF A DEVICE THAT WOULD CLOSE THE HOLE IN THE HEART. ON APPROX TWO MONTHS LATER RESPECTIVELY, PT WAS TAKEN OFF OF COUMADIN AND LOVENOX IN ORDER TO PERFORM THE AMPLATZER PFO CLOSURE OPERATION. DR PERFORMED THE AMPLATZER PFO CLOSURE OPERATION CLOSING THE HOLE IN PT'S HEART AT THE HOSP ON THE SAME MONTH. AN ECHOCARDIOGRAM CONFIRMED THE PLACEMENT WAS "EXCELLENT." DR PRESCRIBED AND PLACED PT BACK ON THE BLOOD THINNERS COUMADIN AND LOVENOX WITHIN HOURS OF THE OPERATION. THE AMPLATZER OCCLUDER IS A MEDICAL PRODUCT MANUFACTURED AND MARKETED BY THE AGA MEDICAL CORP. AT THE TIME OF THE EVENTS DESCRIBED HEREIN, THE AMPLATZER OCCLUDER INSERTED INTO PT WAS APPROVED BY THE FDA UNDER A HUMANITARIAN DEVICE EXEMPTION -HDE- FOR USE AS AN EXPERIMENTAL DEVICE. THE FACT THAT THIS DEVICE WAS EXPERIMENTAL WAS NEVER MADE KNOWN TO PT OR HER HUSBAND AND NOWHERE IN THE PRODUCT LABELING DID AGA MEDICAL CORP WARN THAT NO MORE THAN ONE ANTICOAGULANT SHOULD BE USED DURING THE PROCEDURE. THE PROCEDURE CONSISTS OF INSERTING A TUBE THROUGH THE FEMORAL ARTERY LEADING TO THE HEART FOR PLACEMENT OF THE OCCLUDER. AN ANTICOAGULANT IS OFTEN USED TO MINIMIZE THE RISK OF A STROKE CAUSING CLOT. HOWEVER, MORE THAN ONE ANTICOAGULANT IS CONTRAINDICATED BY THE PROTOCOLS OF ALL MAJOR HEART CENTERS PERFORMING THIS PROCEDURE DUE TO THE INCREASE IN RISK OF A HEMATOMA WHICH, IN THIS CASE, CAUSED SPINAL CORD COMPRESSION AND QUADRIPLEGIA. THE MARKETING OF THIS PRODUCT INCLUDED PACKAGE LABELING WHICH DID NOT WARN PHYSICIANS OR CONSUMERS OF THE DANGERS OF A HEMATOMA WITH MORE THAN ONE ANTICOAGULANT. THIS FAILURE TO WARN MAKES THIS DEVICE UNREASONABLY DANGEROUS TO THE CONSUMER IN WHOM THE DEVICE WAS INSERTED. PT WAS SUPPOSED TO BE DISCHARGED FROM HOSP IN 2005. BUT, AROUND 6:00 A.M. THAT MORNING, SHE COMPLAINED OF A HEADACHE AND WAS GIVEN PERCODAN. HER RELEASE ORDER WAS WITHDRAWN AROUND 12:45 P.M. WITH A MUSCLE RELAXANT AND BREATHING ASSISTANCE MEDICATION BEING PRESCRIBED BY DR. DR ALSO ASKED FOR A CONSULT FROM ANOTHER DR, AN INTERNAL MEDICINE HOSPITALIST, DUE TO A SUDDEN ONSET OF NECK PAIN. DR SAW PT LATER THAT EVENING AND NOTED "ACUTELY" DEVELOPING "UPPER BACK AND NECK PAIN" AS WELL AS "ASSOCIATED DIFFICULTY BREATHING." DR THEN THANKED THE OTHER DR FOR THE CONSULT AND ORDERED AN INCREASE IN BLOOD THINNER OR COUMADIN. AT 8:00 P.M. ON THE SAME DAY, AND AFTER, EMPLOYEES HOSP NOTED PT TO HAVE REDUCED LIMB STRENGTH, "SEVERE WEAKNESS, FOLLOWING DOSES OF MUSCLE RELAXANT PT REC'D FROM PREVIOUS SHIFT FOR MUSCLE SPASM," MOBILITY DIMINISHED FROM "NO LIMITATION" TO "VERY LIMITED MOBILITY," NOT BEING ASSESSED WITHIN "DEFINED PARAMETERS FROM THE CARDIAC REVIEW," NOT BEING ASSESSED WITHIN "DEFINED PARAMETERS FROM THE NEUROLOGIC REVIEW" AND CATHETERIZATION BEING REQUIRED AT 10:00 P.M. AND 25 MINUTES AFTER MIDNIGHT THE FOLLOWING DAY, DESPITE THE NURSING STAFF EARLIER NOTING PT'S ABILITY TO VOID. THE NEXT DAY, PT'S NEUROLOGICAL EXAM WAS MUCH WORSE. SHE HAD SEVERE PAIN. DR WAS INFORMED AROUND 6:10 A.M. OF PT'S INABILITY TO URINATE AND ORDERED CATHETERIZATION. AT 10:30 A.M. ON THE SAME DAY, DR NOTED INABILITY TO VOID LEG AND ARM NUMBNESS AND WEAKNESS, "LOTS OF NECK PAIN" AND DECREASED SENSATION BELOW NECK. HE THEN ORDERED A STAT MRI AND NEUROLOGY CONSULT. THE MRI TAKEN AFTER 10:30 A.M. SHOWED A HEMATOMA COMPRESSING ON THE SPINAL CORD IN THE NECK. A NEUROSURGEON, AWARE OF THE DANGERS ASSOCIATED WITH CORD COMPRESSION, ATTEMPTED TO SURGICALLY REMOVE OR EVACUATE THE HEMATOMA AROUND 1:30 P.M. HIS OPERATIVE REPORT STATED THE COVERING OF THE SPINAL CORD AT C5, 6, AND 7 WAS GROSSLY BLUISH IN COLOR. HE FOUND A SUBDURAL HEMATOMA COMPRESSED ON THE SPINAL CORD ACCORDING TO THE PATHOLOGY REPORT. PT IS NOW DESCRIBED MEDICALLY AS AN "INCOMPLETE QUADRIPLEGIC" WITH LIMITED MOVEMENT OF HER ARMS AND NO MOVEMENT OF HER LEGS. SHE IS PARALYZED. SHE IS TAKEN CARE OF BY HER HUSBAND. SHE ESSENTIALLY LIVES IN A WHEELCHAIR. DESPITE REHAB AT SPINAL CORD CTR, SHE WILL NEVER WALK OR BE MOBILE ON HER OWN AGAIN. SHE IS SUSCEPTIBLE TO PRESSURE SORES AND HAS HAD TO BATTLE AT LEAST ONE. HER DAYS ARE SPEND MOSTLY IN. DATES OF USE: 09/15/2005 - 09/20/2007. DIAGNOSIS OR REASON FOR USE: SMALL HOLE IN HEART KNOWN AS PATENT FORAMEN OVALE OR PFO.