TAXUS (R) LIBERTÉ (R)
Report
- Report Number
- 2134265-2011-01224
- Event Type
- Death
- Date Received
- March 30, 2011
- Date of Event
- December 6, 2010
- Report Date
- March 2, 2011
- Manufacturer
- BOSTON SCIENTIFIC - MAPLE GROVE
- Product Code
- NIQ
- PMA / PMN Number
- P060008
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4).
DESCRIBE EVENT AND RELEVANT LAB DATA UPDATED. (B)(4).
DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).
DESCRIBE EVENT OR PROBLEM, UPN, LOT NUMBER, DEVICE EXPIRATION DATE AND DEVICE MANUFACTORED DATE UPDATED. (B)(4).
(B)(4).
IT WAS FURTHER REPORTED THAT DURING THE HOSPITALIZATION IN (B)(6) 2010, THIS PATIENT WAS NOTED TO HAVE RECEIVED SIX UNITS OF RED BLOOD CELL TRANSFUSION, AND ONE UNIT OF PLATELETS TRANSFUSION.
IT WAS FURTHER REPORTED THAT DURING THE HOSPITALIZATION IN (B)(6) 2010, THIS PATIENT WAS NOTED TO HAVE RECEIVED SIX UNITS OF RED BLOOD CELL TRANSFUSION, AND ONE UNIT OF PLATELETS TRANSFUSION.
IT WAS FURTHER REPORTED THAT AFTER THE CARDIAC ARREST, THE PATIENT RECEIVED ACLS PROTOCOL AND WAS SUCCESSFULLY RESUSCITATED, BEING SHOCKED THREE TIMES. THE PATIENT WAS THEN ADMITTED TO THE INTENSIVE CARE UNIT (ICU). THE PATIENT'S LEVEL OF CONSCIOUSNESS WORSENED AND THE PATIENT WAS DISPLAYING POSTURING, CONCERNING FOR POSSIBLE HYPOXIC ENCEPHALOPATHY. AN ELECTROENCEPHALOGRAM ON (B)(6) 2011 REVEALED ABNORMAL ACTIVITY REFLECTING THE PRESENCE OF SEVERE DIFFUSE METABOLIC ENCEPHALOPATHY. NEUROLOGY HAD NOTED THAT THE PATIENT HAD DECREASED IN THE (B)(6) SCALE ON ADMISSION FROM A SCORE OF 9 TO 8. A CT SCAN OF THE HEAD DID NOT REVEAL ANY ACUTE INTRACRANIAL LESIONS. THE CERVICAL SPINE REVEALED DEGENERATIVE SPONDYLOSIS, SCOLIOSIS, FACET JOINT DISEASE, AND MEDIAN ATLANTOAXIAL DEGENERATIVE JOINT DISEASE. THERE WAS NO ACUTE FRACTURE IDENTIFIED AND AN ENDOTRACHEAL TUBE AND NASO-GASTRIC TUBE WERE NOTED TO BE IN PLACE. AN ECHOCARDIOGRAM WAS REPORTED TO REVEAL INFERIOR, INFEROLATERAL SEVERE HYPOKINESIS. A CARDIAC CATHERIZATION WAS CONSIDERED, BUT DEPENDED ON IMPROVEMENT ON THE PATIENT'S NEUROLOGIC STATUS. THE PATIENT DID DEVELOP A FEVER AND THROMBOCYTOPENIA RELATED TO ANTIBIOTICS, WITH THE POSSIBILITY OF ASPIRATION PNEUMONITIS BEING CONSIDERED. THE PATIENT WAS TO BE TREATED FOR 10 DAYS WITH BROAD SPECTRUM ANTIBIOTICS. A DROP OF THE WHITE BLOOD CELL COUNT FROM 30,000 TO 16,000 AND A DECREASE IN THE FEVER RESULTED IN THE PATIENT BEING DISCONTINUED FROM VANCOMYCIN AND CEFTAZIDIME. THE PATIENT WAS CONSIDERED FOR A TRACHEOSTOMY AFTER BEING UNABLE TO BE WEANED OFF VENTILATOR SUPPORT. THE PATIENT WAS CONSIDERED A NEED FOR LONG TERM NUTRITION DUE TO MULTIORGAN INVOLVEMENT AND A POSSIBLY ISCHEMIC LIVER. THE PATIENT WAS CONSIDERED FOR A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY. THE PATIENT DEVELOPED ACUTE RENAL FAILURE, SUSPECTED ACUTE TUBULAR NECROSIS FROM HYPOTENSION, FEVERS, AND PRE-RENAL AZOTEMIA. THE PATIENT WAS DESCRIBED TO HAVE AN ELEVATED POTASSIUM LEVEL SECONDARY TO THE ACUTE RENAL FAILURE AND METABOLIC RESPIRATORY ACIDOSIS. THE PATIENT WAS CHANGED FROM IV GLUCERNA TO NEPRO, AND WAS CONSIDERED FOR THE POSSIBILITY OF DIALYSIS IF HE DID NOT RESPOND TO THE PRESCRIBED MEDICAL MANAGEMENT. A TRIPLE-LUMEN CATHETER WITH A BACTERIAL LINE INSERTION WAS PERFORMED TO THE PATIENT. LEVOPHED WAS STARTED FOR PRESSOR SUPPORT. THE PATIENT EXPERIENCED AN EPISODE OF AGITATION, TACHYCARDIA, HYPERTENSION, AND VENTRICULAR TACHYCARDIA RESPONSIVE TO SHOCKING. THE CAUSE OF THIS EPISODE WAS UNCLEAR, AS THE SEDATION AND ANALGESIA WAS DISCONTINUED AT THE TIME OF THIS OCCURRENCE. THE PATIENT HAD RECEIVED MRI AND MRA SCANS OF THE BRAIN, PERFORMED TO ASSESS FOR HYPOXIC VERSUS ANOXIC INJURY OR A FOCAL ISCHEMIC EVENT, REVEALED THE NORMAL FINDINGS. THE PATIENT CONTINUED TO DISPLAY THROMBOCYTOPENIA WHICH WAS CONSIDERED TO BE SECONDARY TO SEPSIS. BLOOD CULTURE REVEALED COAGULASE-NEGATIVE (B)(6). THE PATIENT RECEIVED PLATELET TRANSFUSIONS. THE PATIENT'S NEUROLOGIC SYMPTOMS DID NOT IMPROVE. THE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY WAS NOT PERFORMED AT THE REQUEST OF THE FAMILY. A DEATH CERTIFICATE RECEIVED REVEAL THE PATIENT THE CAUSE OF DEATH ATTRIBUTED TO ANOXIC ENCEPHALOPATHY AND ACUTE MI.
IT WAS FURTHER REPORTED THAT IN THE INDEX PROCEDURE A 2.75X32MM AND 2.75X8MM TAXUS LIBERTE STENTS WERE IMPLANTED.
(B)(4). SAME CASE AS 2134265-2011-01225. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPIRED. THE LESION BEING TREATED WAS LOCATED IN THE RAMUS. THE PHYSICIAN IMPLANTED TWO TAXUS LIBERTE STENTS OF UNKNOWN SIZE. POST PROCEDURE RESIDUAL STENOSIS WAS 0% WITH TIMI III FLOW. PRIOR TO THE INDEX PROCEDURE THE PATIENT RECEIVED A PERI-PROCEDURAL LOADING DOSE OF CLOPIDOGREL. THE DAY AFTER THE INDEX PROCEDURE, THE PATIENT WAS STARTED ON CLOPIDOGREL AND ASPIRIN. THE PATIENT WAS DISCHARGED 2 DAYS POST INDEX PROCEDURE. IN (B)(6) 2010, THE PATIENT WAS REPORTED TO HAVE BEEN ADMITTED TO THE HOSPITAL AFTER A WITNESSED CARDIAC ARREST AT WORK. THE SITE REPORTED THAT A HYPOTHERMIA PROTOCOL WAS PERFORMED. THE PATIENT WAS UNRESPONSIVE AND WAS INTUBATED. THE SITE DESCRIBED THE PATIENT TO BE "SEDATED" AND "PARALYZED". AGGRESSIVE MEDICAL MANAGEMENT WAS PERFORMED DURING THIS HOSPITALIZATION WITH IV AMIODARONE, BETA-BLOCKERS, IV HEPARIN, STATIN, ASPIRIN, AND PLAVIX. AN EEG, ECHOCARDIOGRAM, HID-A SCAN, BRAIN MRA AND MRI WERE PERFORMED. THE PATIENT WAS EVENTUALLY TRANSFERRED TO HOSPICE CARE WHERE THE PATIENT EXPIRED 30 DAYS LATER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TAXUS (R) LIBERTÉ (R) | CORONARY DRUG-ELUTING STENT | NIQ | BOSTON SCIENTIFIC - MAPLE GROVE | H7493893632270 | 0012433852 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Death | TAXUS LIBERTE STENT |