TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Report
- Report Number
- 2134265-2011-01686
- Event Type
- Malfunction
- Date Received
- May 10, 2011
- Date of Event
- April 17, 2011
- Report Date
- April 18, 2011
- Manufacturer
- BOSTON SCIENTIFIC - MAPLE GROVE
- Product Code
- NIQ
- PMA / PMN Number
- P060008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
DEVICE EVALUATED BY MFR: THE TAXUS LIBERTE DEVICE WAS RETURNED WITH NO VISIBLE BLOOD OR CONTRAST ON THE DEVICE. MAGNIFIED INSPECTION CONFIRMED THAT THE PROXIMAL END OF THE STENT WAS DAMAGED. THERE WERE BENT AND STRETCHED STRUTS IN SEVERAL ROWS OF PROXIMAL STRUTS. INSPECTION OF THE DISTAL END OF THE STENT CONFIRMED THAT THE STENT DID NOT DISLODGE FROM THE AS-MANUFACTURED POSITION BETWEEN THE MARKERBANDS. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).
DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).
(B)(4).
IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED POSTERIOR DESCENDING ARTERY (PDA). A 2.25X12MM TAXUS LIBERTE ATOM STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE PDA; HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION. THE DEVICE WAS REMOVED FROM THE PATIENT AND IT WAS NOTED THAT THE STENT STRUTS WERE FRAYED. A NON BSC BALLOON WAS THEN ADVANCED TO THE LESION AND INFLATED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER 2.25X12MM TAXUS LIBERTE ATOM STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT CONDITION IS FINE.
IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED POSTERIOR DESCENDING ARTERY (PDA). A 2.25X12MM TAXUS LIBERTE ATOM STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE PDA; HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION. THE DEVICE WAS REMOVED FROM THE PATIENT AND IT WAS NOTED THAT THE STENT STRUTS WERE FRAYED. A NON BSC BALLOON WAS THEN ADVANCED TO THE LESION AND INFLATED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER 2.25X12MM TAXUS LIBERTE ATOM STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT CONDITION IS FINE.
IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE STENT DAMAGE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED POSTERIOR DESCENDING ARTERY (PDA). A 2.25X12MM TAXUS LIBERTE ATOM STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE PDA; HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION. THE DEVICE WAS REMOVED FROM THE PATIENT AND IT WAS NOTED THAT THE STENT STRUTS WERE FRAYED. A NON BSC BALLOON WAS THEN ADVANCED TO THE LESION AND INFLATED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER 2.25X12MM TAXUS LIBERTE ATOM STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT CONDITION IS FINE.
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 | H7493893612220 | 13563008 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR |