TAXUS® LIBERTÉ®
Report
- Report Number
- 2134265-2013-00967
- Event Type
- Injury
- Date Received
- February 27, 2013
- Date of Event
- June 30, 2012
- Report Date
- January 29, 2013
- Manufacturer
- BOSTON SCIENTIFIC - MAPLE GROVE
- Product Code
- NIQ
- PMA / PMN Number
- P060008
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
DEVICE IS COMBINATION PRODUCT. (B)(6). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).
(B)(4). IT WAS REPORTED THAT POST CORONARY STENTING TREATMENT PROCEDURE, BLEEDING AND MYOCARDIAL INFARCTION OCCURRED. IN (B)(6) 2010, THE SUBJECT PRESENTED WITH UNSTABLE ANGINA (BRAUNWALD CLASSIFICATION: IIB). CARDIAC CATHETERIZATION WAS RECOMMENDED AND REVEALED 99% STENOSED LONG LESION LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) AND EXTENDING TO THE DISTAL RCA. THE LESION WAS 25 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.6 MM AND TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 X 32 MM TAXUS LIBERTE STENT, WITH 0 % RESIDUAL STENOSIS. THE FOLLOWING DAY, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2012, THE SUBJECT PRESENTED WITH PRODUCTIVE COUGH, SHORTNESS OF BREATH AND FEVER. CHEST X-RAY WAS PERFORMED AND THE SUBJECT WAS SUBSEQUENTLY DIAGNOSED WITH BIBASILAR PNEUMONIA AND POSSIBLE ACUTE EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE. ANTIBIOTICS WERE PRESCRIBED AND THE SUBJECT WAS HOSPITALIZED. THREE DAYS LATER, CT SCAN OF THE THORAX (WITHOUT CONTRAST) REVEALED DIFFUSE BILATERAL ALVEOLAR OPACITIES CONSISTENT WITH ADULT RESPIRATORY DISTRESS SYNDROME (ARDS). THE SUBJECT DEVELOPED HYPOXIA AND WAS AIR-LIFTED TO ANOTHER FACILITY FOR FURTHER EVALUATION AND MANAGEMENT. THE SUBJECT EXPERIENCED ACUTE RESPIRATORY FAILURE AND WAS SUBSEQUENTLY INTUBATED. OVER THE COURSE OF HOSPITALIZATION, THE SUBJECT DEVELOPED SEPTIC SHOCK SECONDARY TO ARDS. AMV WAS REQUIRED AND ANTIBIOTIC THERAPY CONTINUED. THREE DAYS LATER, CARDIAC ENZYMES WERE FOUND TO BE ELEVATED CONSISTENT WITH PROTOCOL DEFINITION FOR MI. NO ISCHEMIC SYMPTOMS WERE NOTED. AT THE TIME OF THE EVENT, THE SUBJECT WAS TAKING ASPIRIN AND CLOPIDOGREL. THE STUDY DRUG WAS LAST TAKEN ON (B)(6) 2011. CARDIOLOGY WAS CONSULTED AND THE SUBJECT WAS PLACED ON HEPARIN DRIP AND VASOPRESSOR. NINE DAYS LATER, HEMATOLOGY MEASUREMENTS REVEALED HEMOGLOBIN OF 6.6 G/DL (REFERENCE RANGE 14-18 G/DL) AND HEMATOCRIT OF 20.7% (REFERENCE RANGE 42-52%). GUSTO CLASSIFICATION: SEVERE. THE SUBJECT'S ABDOMEN WAS NOTED TO BE DISTENDED; CT SCAN OF ABDOMEN/PELVIS (WITH CONTRAST) REVEALED A LARGE RECTUS SHEATH HEMATOMA. THE SUBJECT WAS TRANSFUSED WITH 5 UNITS, 3 UNITS AND 4 UNITS OF PRBCS RESPECTIVELY. TWO DAYS LATER THE EVENT OF LARGE RECTUS SHEATH HEMATOMA WAS CONSIDERED TO BE RESOLVED WITHOUT RESIDUAL EFFECTS. IN (B)(6) 2012, THE SUBJECT DEVELOPED SWELLING IN THE LEFT LOWER EXTREMITY. THE FOLLOWING DAY, DOPPLER SCAN REVEALED DEEP VEIN THROMBOSIS IN THE LEFT FEMORAL ARTERY WHICH WAS TREATED WITH PLACEMENT OF AN IVC FILTER. TWO DAYS LATER, THE EVENT OF NON ST ELEVATION MI WAS CONSIDERED TO BE RESOLVED WITHOUT RESIDUAL EFFECTS AND THE SUBJECT WAS TRANSFERRED TO INPATIENT REHABILITATION. SEVEN DAYS LATER, THE EVENT OF COPD EXACERBATION CONSIDERED TO BE RESOLVED WITHOUT RESIDUAL EFFECTS SUBJECT WAS DISCHARGED ON THE SAME DAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 84202 | TAXUS® LIBERTÉ® | CORONARY DRUG-ELUTING STENT | NIQ | BOSTON SCIENTIFIC - MAPLE GROVE | H7493893632250 | 13053965 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Hospitalization| R |