TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Report
- Report Number
- 2134265-2010-03373
- Event Type
- Malfunction
- Date Received
- August 3, 2010
- Date of Event
- July 5, 2010
- Report Date
- July 12, 2010
- Manufacturer
- BOSTON SCIENTIFIC - GALWAY
- Product Code
- NIQ
- PMA / PMN Number
- P060008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4).
DEVICE EVALUATED BY MANUFACTURER - A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED DISTAL STENT DAMAGE. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE STENT MEETING RESISTANCE UPON ADVANCEMENT AND/OR WITHDRAWAL. THE BALLOON AND TIP SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. A VISUAL AND MICROSCOPIC EXAMINATION IDENTIFIED KINKS ALONG THE ENTIRE LENGTH OF THE HYPOTUBE SHAFT. ATTEMPTS TO INSERT A PRODUCT MANDREL WERE UNSUCCESSFUL DUE TO SOLIDIFIED BLOOD PRESENT WITHIN THE ENTIRE LENGTH OF THE LUMEN. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).
IT WAS REPORTED THAT DURING A DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE VASCULAR ACCESS SITE WAS OBTAINED VIA THE RIGHT RADIAL ARTERY. ANGIOGRAPHY SHOWED AN ECCENTRIC, DE NOVO 2.5MM X 25MM CHRONIC TOTAL OCCLUSION (CTO) LESION IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED DISTAL RIGHT CORONARY ARTERY (RCA). ADDITIONALLY THERE WAS A GREATER THAN OR EQUAL TO 45 DEGREE BEND IN THE LESION. A NON-BSC 6FR JR4.0 GUIDE CATHETER ALONG WITH A NON-BSC 190CM 0.014 GUIDE WIRE WERE ADVANCED TO THE LESION SITE. NEXT, THE LESION WAS PRE-DILATED WITH A NON-BSC 1.25X15MM BALLOON FOUR TIMES TO 18ATMS FOR 10 SECONDS ON EACH INFLATION. IMMEDIATELY AFTER PRE-DILATATION RESIDUAL STENOSIS WAS NOTED TO BE 80%. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A TAXUS LIBERTE' 2.25X12MM STENT TO THE LESION SITE BUT THE STENT WOULD NOT CROSS THE LESION. THE STENT DELIVERY SYSTEM WAS (SDS) WAS WITHDRAWN FROM THE PATIENT AND IT WAS NOTED THE STENT STRUTS WERE RAISED. THE PHYSICIAN DECIDED TO END THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.
IT WAS REPORTED THAT DURING A DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE VASCULAR ACCESS SITE WAS OBTAINED VIA THE RIGHT RADIAL ARTERY. ANGIOGRAPHY SHOWED AN ECCENTRIC, DE NOVO 2.5MM X 25MM CHRONIC TOTAL OCCLUSION (CTO) LESION IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED DISTAL RIGHT CORONARY ARTERY (RCA). ADDITIONALLY THERE WAS A GREATER THAN OR EQUAL TO 45 DEGREE BEND IN THE LESION. A NON-BSC 6FR JR4.0 GUIDE CATHETER ALONG WITH A NON-BSC 190CM 0.014 GUIDE WIRE WERE ADVANCED TO THE LESION SITE. NEXT, THE LESION WAS PRE-DILATED WITH A NON-BSC 1.25X15MM BALLOON FOUR TIMES TO 18ATMS FOR 10 SECONDS ON EACH INFLATION. IMMEDIATELY AFTER PRE-DILATATION RESIDUAL STENOSIS WAS NOTED TO BE 80%. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A TAXUS LIBERTE' 2.25X12MM STENT TO THE LESION SITE BUT THE STENT WOULD NOT CROSS THE LESION. THE STENT DELIVERY SYSTEM WAS (SDS) WAS WITHDRAWN FROM THE PATIENT AND IT WAS NOTED THE STENT STRUTS WERE RAISED. THE PHYSICIAN DECIDED TO END THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.
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 | H7493894012220 | 12832378 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | RYJUIN 1.25X15MM BALLOON CATHETER| PILOT 50 - 190CM 0.014 GUIDE WIRE| LAUNCHER 6FR JR4.0 GUIDE CATHETER |