TAXUS® LIBERTÉ®
Report
- Report Number
- 2134265-2013-00381
- Event Type
- Injury
- Date Received
- February 6, 2013
- Date of Event
- April 30, 2010
- Report Date
- January 8, 2013
- Manufacturer
- BOSTON SCIENTIFIC - MAPLE GROVE
- Product Code
- NIQ
- PMA / PMN Number
- P060008
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(6). DEVICE IS A 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. THE MANUFACTURING BATCH RECORD REVIEW CONFORMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATION AS THE REPORTED EVENT IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE PRODUCT DIRECTIONS FOR USE (DFU) AND/OR DEVICE LABELING. (B)(4).
(B)(6). SAME PATIENT AS MDR ID#: (B)(6). SAME CASE AS MDR ID#: 2134265-2013-00380, 2134265-2013-00382. IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT HAD CHEST PAIN. IN (B)(6) 2010, THE PATIENT PRESENTED WITH UNSTABLE ANGINA (BRAUNWALD CLASSIFICATION IIB) AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE 1ST TARGET LESION WAS A LONG LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (PROX RCA) EXTENDING INTO THE MID RCA WITH 75% STENOSIS AND WAS 15 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00 MM. WHILE PLACING A 3.00 X 28 MM TAXUS LIBERTE STENT AFTER PRE-DILATION, THE PATIENT EXPERIENCED CHEST PAIN RATED AT A SCALE OF 6 OUT OF 10. THE PATIENT WAS GIVEN INTRAVENOUS 25 MCG FENTANYL FOR SEDATION. THE 3.00 X 28 MM TAXUS LIBERTE STENT WAS EVENTUALLY DEPLOYED IN THE PROX RCA. RESIDUAL STENOSIS WAS 0% FOLLOWING POST-DILATION. THE PATIENT CONTINUED TO EXPERIENCE CHEST PAIN RATED AT A SCALE OF 5 OUT OF 10. THE 2ND TARGET LESION WAS A LONG LESION WITH PRE-EXISTING THROMBUS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (DIST RCA) EXTENDING INTO THE RIGHT POSTERIOR DESCENDING ARTERY (R-PDA) WITH 99% STENOSIS AND WAS 8 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AND PLACEMENT OF A 3.00 X 24 MM TAXUS LIBERTE STENT. FOLLOWING STENT DEPLOYMENT, AN EDGE DISSECTION WAS NOTED, WHICH WAS TREATED WITH PLACEMENT OF A 3.00 X 20 MM TAXUS LIBERTE STENT, OVERLAPPING PROXIMALLY WITH THE PREVIOUSLY DEPLOYED 3.00 X 24 MM TAXUS LIBERTE STENT. RESIDUAL STENOSIS WAS 0% FOLLOWING POST-DILATION. THE 3RD TARGET LESION WAS LOCATED IN THE PROX RCA WITH 70% STENOSIS AND WAS 10 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00 MM. THE PHYSICIAN TREATED THE LESION WITH DIRECT PLACEMENT OF A 3.00 X 16 MM TAXUS LIBERTE STENT, OVERLAPPING DISTALLY WITH THE 3.00 X 28 MM TAXUS LIBERTE STENT. RESIDUAL STENOSIS WAS 0% FOLLOWING POST-DILATION. AT THIS TIME, THE PATIENT DID NOT HAVE ANY RELIEF AND CONTINUED TO HAVE CHEST PAIN. THUS 50 MCG FENTANYL IV WAS GIVEN FOR SEDATION. THE 4TH TARGET LESION WAS LOCATED IN THE DIST RCA WITH 70% STENOSIS AND WAS 5 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00 MM. THE PHYSICIAN TREATED THE LESION WITH DIRECT PLACEMENT OF A 2.50 X 16 MM TAXUS LIBERTE STENT, OVERLAPPING PROXIMALLY WITH THE 3.00 X 20 MM TAXUS LIBERTE STENT. RESIDUAL STENOSIS WAS 0% FOLLOWING POST-DILATION. IT WAS NOTED THAT THE 2.50 X 16 MM STENT WAS ALSO A BAILOUT STENT WHICH WAS USED TO TREAT A DISSECTION CAUSED BY THE STUDY STENT. AT THE END OF THE PROCEDURE, THE PATIENT WAS NOTED TO HAVE ACCEPTABLE CHEST PAIN AND NO FURTHER INTERVENTION WAS PERFORMED. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 51101 | TAXUS® LIBERTÉ® | CORONARY DRUG-ELUTING STENT | NIQ | BOSTON SCIENTIFIC - MAPLE GROVE | H7493893620300 | 13002758 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |