TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Report
- Report Number
- 2134265-2011-00324
- Event Type
- Injury
- Date Received
- February 16, 2011
- Date of Event
- September 1, 2010
- Report Date
- January 19, 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
DEVICE IS COMBINATION PRODUCT. PATIENT IDENTIFIER: (B)(6). DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED 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).
(B)(4).
(B)(4). IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION. THE PATIENT PRESENTED WITH STABLE ANGINA (CCS CLASS 3) AND UNDERWENT CARDIAC CATHETERIZATION WHICH REVEALED A 95% STENOSED AND 20MM LONG TARGET LESION IN THE DISTAL LEFT CIRCUMFLEX (LCX) CORONARY ARTERY. THE PHYSICIAN COMMENTED THAT IT WAS A DIFFICULT VESSEL TO WIRE. AN INITIAL ATTEMPT TO PLACE A ROTAWIRE WAS UNSUCCESSFUL. THE LESION WAS PREDILATED AND THEN THE ROTAWIRE CROSSED AND 2 PASSES WERE MADE WITH A 1.25MM BURR WITH "NO DECELERATIONS > 5K". A BUDDY WIRE WAS THEN USED AND THE 4.0X24MM TAXUS LIBERTE STENT WAS ADVANCED AND DEPLOYED RESULTING IN 0% RESIDUAL STENOSIS. THE PHYSICIAN REPORTS THAT THERE WAS A GOOD RESULT, BUT THAT A SMALL OBTUSE MARGINAL BRANCH WAS OCCLUDED AND WAS UNABLE TO BE REWIRED. ELEVATED CARDIAC ENZYMES INDICATE THE PATIENT EXPERIENCED A PERIPROCEDURAL MYOCARDIAL INFARCTION. THE SITE REPORTS THAT THE EVENT MAY HAVE BEEN CAUSED BY THE OCCLUSION TO THE OM. THE EVENT WAS TREATED WITH MEDICAL THERAPY AND IS LISTED AS RESOLVED WITHOUT RESIDUAL EFFECTS. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL.
IT WAS FURTHER REPORTED THAT THE SUBJECT STAYED AN EXTRA NIGHT FOR OBSERVATION FOLLOWING THE EVENT BUT THAT NO MEDICATION WAS GIVEN TO TREAT THE EVENT.
(B)(4). IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION. THE PATIENT PRESENTED WITH STABLE ANGINA (CCS CLASS 3) AND UNDERWENT CARDIAC CATHETERIZATION WHICH REVEALED A 95% STENOSED AND 20MM LONG TARGET LESION IN THE DISTAL LEFT CIRCUMFLEX (LCX) CORONARY ARTERY. THE PHYSICIAN COMMENTED THAT IT WAS A DIFFICULT VESSEL TO WIRE. AN INITIAL ATTEMPT TO PLACE A ROTAWIRE WAS UNSUCCESSFUL. THE LESION WAS PREDILATED AND THEN THE ROTAWIRE CROSSED AND 2 PASSES WERE MADE WITH A 1.25MM BURR WITH "NO DECELERATIONS > 5K". A BUDDY WIRE WAS THEN USED AND THE 4.0X24MM TAXUS LIBERTE STENT WAS ADVANCED AND DEPLOYED RESULTING IN 0% RESIDUAL STENOSIS. THE PHYSICIAN REPORTS THAT THERE WAS A GOOD RESULT, BUT THAT A SMALL OBTUSE MARGINAL BRANCH WAS OCCLUDED AND WAS UNABLE TO BE REWIRED. ELEVATED CARDIAC ENZYMES INDICATE THE PATIENT EXPERIENCED A PERIPROCEDURAL MYOCARDIAL INFARCTION. THE SITE REPORTS THAT THE EVENT MAY HAVE BEEN CAUSED BY THE OCCLUSION TO THE OM. THE EVENT WAS TREATED WITH MEDICAL THERAPY AND IS LISTED AS RESOLVED WITHOUT RESIDUAL EFFECTS. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL.
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 - MAPLE GROVE | H7493893624400 | 0013136304 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention | ROTAWIRE AND 1.25MM BURR |