TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Report
- Report Number
- 2134265-2010-05476
- Event Type
- Injury
- Date Received
- December 6, 2010
- Date of Event
- November 10, 2010
- Report Date
- November 10, 2010
- Manufacturer
- BOSTON SCIENTIFIC - GALWAY
- Product Code
- NIQ
- PMA / PMN Number
- P060008
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PHYSICIAN
Narratives
DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: 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).
SAME CASE AS MFR ID: 2134265-2010-05475, 2134265-2010-05477, 2134265-2010-05478, 2134265-2010-05479. SAME PATIENT AS MFR ID: 2134265-2010-05474. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, STENT THROMBOSIS OCCURRED. THE PATIENT PRESENTED DUE TO NON-ST ELEVATION MYOCARDIAL INFARCTION AND UNDERWENT CARDIAC CATHETERIZATION. ACCESS WAS GAINED VIA THE RIGHT FEMORAL ARTERY WITH A 5F SIDE PORT SHEATH AND A JL4 GUIDE CATHETER. ANGIOGRAPHY REVEALED TARGET LESIONS IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY AND SECOND DIAGONAL BRANCH. THE LAD WAS DESCRIBED AS HAVING A LONG 80% STENOSED LESION DISTALLY AND AN 80% STENOSED LESION IN THE MID PORTION OF THE VESSEL JUST AFTER THE OSTIUM TO THE SECOND DIAGONAL ARTERY. IN THE SECOND DIAGONAL ARTERY, THERE IS A 75% STENOSED LESION WITH "QUESTION OF CLOT NOTED." NON-BSC WIRES WERE USED TO ENGAGE BOTH THE DIAGONAL AND DISTAL LAD. A 2.0X15MM APEX BALLOON WAS ADVANCED AND USED TO PREDILATE THE DIAGONAL LESION TO 15ATM. A 2.5X16MM TAXUS LIBERTE STENT WAS POSITIONED AND DEPLOYED TO 12ATM IN THE DIAGONAL. THERE WAS A STEP DOWN DISTALLY AND A 2.25X8MM TAXUS LIBERTE STENT WAS DEPLOYED AT 14ATM. THE PROXIMAL STENT WAS THEN POST DILATED AND ANGIOGRAPHY CONFIRMED SATISFACTORY PLACEMENT. A 2.0X20MM APEX BALLOON WAS ADVANCED TO THE LAD LESION AND INFLATED TO 8ATM. THE LAD WAS THEN ADDRESSED WITH DEPLOYMENT OF A 2.25X28MM TAXUS LIBERTE STENT AT 12ATM. THE LAD WAS THEN TREATED WITH INFLATION OF A 2.5X12MM APEX BALLOON AT 10ATM AND THE DIAGONAL TREATED WITH A 2.5X12MM APEX BALLOON INFLATED TO 12ATM. THE LESION IN THE LAD DISTAL TO THE DIAGONAL WAS TREATED WITH A 2.75X16MM STENT DEPLOYED AT 12ATM. AT THIS TIME, THERE WAS A PLAQUE SHIFT NOTED SO DIAGONAL WAS REWIRED AND TREATED WITH DILATION USING A 3.0X12MM QUANTUM APEX BALLOON INFLATED TO 3ATM. ANGIOGRAPHY CONFIRMED SATISFACTORY PLACEMENT. THERE WAS A STEP DOWN JUST DISTAL TO THE LAD STENT WITH HAZINESS NOTED BETWEEN THE TWO STENTS IN THE LAD, SO A 2.75X12MM TAXUS LIBERTE WAS IMPLANTED AT 10ATM TO TREAT THIS AREA. FOLLOW UP ANGIOGRAPHY CONFIRMED SUCCESSFUL TREATMENT OF THE TARGET VESSELS WITH RESIDUAL STENOSIS IN THE TREATED SEGMENTS TO BE LESS THEN 5%. THREE DAYS LATER, WHILE STILL HOSPITALIZED FOR THE INITIAL PROCEDURE, THE PATIENT WAS BROUGHT BACK TO THE CATH LAB TO ADDRESS SYMPTOMS INCLUDING CHEST PAIN AND ST ELEVATION. ACCESS WAS GAINED VIA THE LEFT FEMORAL ARTERY AND A 6F SIDEPORT SHEATH. ANGIOGRAPHY REVEALED EVIDENCE OF STENT THROMBOSIS OF THE DIAGONAL AND LAD STENTS. A NON BSC GUIDE WIRE WAS USED TO CROSS THE LAD AND THE VESSEL WAS DILATED WITH A 2.0X15MM APEX BALLOON. A NON BSC GUIDE WIRE THEN CROSSED THE DIAGONAL BRANCH AND THE AREA TREATED WITH DILATION OF A 2.0X12MM APEX BALLOON. A 1.5X12MM APEX BALLOON WAS ADVANCED AND THE DIAGONAL TREATED WITH MULTIPLE INFLATIONS. A 2.25X24MM TAXUS LIBERTE STENT WAS THEN POSITIONED AND DEPLOYED AT 10ATM OVERLAPPING WITH THE PREVIOUSLY PLACED STENTS. AT THIS TIME, THERE WAS EVIDENCE OF A PERFORATED AREA NOTED WITHIN THE STENTED AREA. A 2.5X20MM QUANTUM BALLOON WAS ADVANCED FOR SEVERAL LONG INFLATIONS AND THE ST ELEVATIONS CAME DOWN ONLY TO GO BACK UP WITH RESTORED FLOW. THE CLOT AND PERFORATION PERSISTED SO THE AREA WAS STENTED WITH A 2.5X16MM TAXUS LIBERTE STENT AND A 2.5X8MM TAXUS LIBERTE STENT. PROLONGED INFLATIONS WERE DONE USING A SDS BALLOON WHICH SEEMED TO BE TOLERATED WITHOUT ANY FURTHER ST ELEVATION AND RESOLVED POST STENTING. HOWEVER, THERE WAS FREE FLOW INTO THE LEFT VENTRICLE FROM THE PERFORATION. ECHOCARDIOGRAM CONFIRMED MINIMAL PERICARDIAL EFFUSION. A 3.0X12MM JOSTENT WAS ADVANCED, AND WITH SEVERAL WIRE CHANGES, IT WAS UNABLE TO CROSS THE PROXIMAL LAD STENT. AN ATTEMPT WAS MADE TO PASS A 3.0X15MM QUANTUM APEX NON COMPLIANT BALLOON TO FURTHER DILATE THE AREA, BUT THERE WAS AGAIN DIFFICULTY CROSSING THE STENTED MID LAD SEGMENT. AT THIS TIME, DUE TO THE LENGTH OF THE PROCEDURE AND CONTRAST LEVELS, IT WAS DECIDED TO END THE PROCEDURE. THE PATIENT WAS HEMODYNAMICALLY STABLE. THE TREATMENT OF THE THROMBOSIS IN BOTH THE LAD AND DIAGONAL BRANCH WAS REPORTED TO BE SUCCESSFUL WITH TIMI-3 FLOW ACHIEVED. AN INTRA AORTIC PUMP WAS POSITIONED AND THE PATIENT PUT IN 1:1 PUMPING. PRIOR TO DISCHARGE, THE DECISION WAS MADE TO RE-IMAGE THE PATIENT. SIX DAYS AFTER THE PREVIOUS CATHETERIZATION, ANGIOGRAPHY CONFIRMED THE STENTED AREAS REMAINED PATENT. THE PERFORATED AREA WAS VIEWED AND REPORTED TO BE STABLE WITH FREE FLOW INTO THE LEFT VENTRICLE. THE PATIENT WAS HEMODYNAMICALLY STABLE AND HAS BEEN DISCHARGED UNDER MEDICAL MANAGEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM | CORONARY DRUG-ELUTING STENT | NIQ | BOSTON SCIENTIFIC - GALWAY | H749389368220 | 0012916743 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Hospitalization| R | 2.5X16MM TAXUS LIBERTE STENT| 2.5X12MM APEX BALLOON| 0.014X190CM BMW TURBOCOAT GUIDE WIRE| 2.0X15MM APEX BALLOON| 2.75X12MM TAXUS LIBERTE STENT| 2.75X16MM TAXUS LIBERTE STENT| 2.25X28MM TAXUS LIBERTE STENT| 6F FL4 100CM MACH1 GUIDE CATHETER| 2.0X20MM APEX BALLOON| 3.0X12MM QUANTUM APEX NC BALLOON X2 |