TAXUS ELEMENT PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Report
- Report Number
- 2134265-2012-07440
- Event Type
- Injury
- Date Received
- December 10, 2012
- Date of Event
- December 8, 2011
- Report Date
- November 8, 2012
- Manufacturer
- BOSTON SCIENTIFIC - GALWAY
- Product Code
- NIQ
- PMA / PMN Number
- P100023
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HU
- Reporter Occupation
- PHYSICIAN
Narratives
DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. 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).
AGE AT TIME OF EVENT, AGE AT TIME OF EVENT (UNIT), PATIENT SEX, DESCRIBE EVENT OR PROBLEM, RELEVANT TESTS/LAB DATA, OTHER RELEVANT HISTORY, IF IMPLANTED, GIVE DATE, PATIENT CODES, DEVICE CODES: UPDATED. (B)(4).
(B)(4). SAME CASE AS MDR #2134265-2012-07439. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, TARGET VESSEL REVASCULARIZATION WAS PERFORMED. ON AN UNKNOWN DATE OR DATES, A 2.75 X 24MM TAXUS ELEMENT STENT WAS IMPLANTED TO TREAT A TARGET LESION LOCATED IN THE FIRST DIAGONAL (1ST DIAG) AND A 3.0 X 24MM TAXUS ELEMENT STENT WAS IMPLANTED TO TREAT A TARGET LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA). IN (B)(6) 2011, REVASCULARIZATION WAS PERFORMED ON A NATIVE LESION IN THE 1ST DIAG. IN (B)(6) 2011, REVASCULARIZATION WAS PERFORMED ON NATIVE LESIONS IN THE 1ST DIAG AND THE DISTAL RCA.
IT WAS FURTHER REPORTED THAT: THE PATIENT PRESENTED FOR THE INDEX PROCEDURE DUE TO STABLE ANGINA AND A POSITIVE STRESS TEST. POST PROCEDURE RESIDUAL STENOSIS WAS 0% WITH POST TIMI GRADE FLOW OF 3 FOR BOTH STENTS. THE PATIENT DID NOT RECEIVE A PERI-PROCEDURAL LOADING DOSE OF THE THIENOPYRIDINE MEDICATION. THE PATIENT WAS DISCHARGED FROM THE INDEX HOSPITALIZATION. AT THE TIME OF THE (B)(6) 2011 EVENT THE PATIENT PRESENTED WITH ANGINA PECTORIS ONE DAY AFTER LAST DOSE OF STUDY MEDICATION. THE PATIENT WAS HOSPITALIZED FOR A PLANNED RECORONAROGRAPHY DUE TO RECURRENT ANGINA PECTORIS AFTER ERGOMETRY. THE PATIENT'S LABORATORY RESULTS INCLUDED HEMOGLOBIN (HGB) 105 G/L, HEMATOCRIT (HTK) 0.32 L/L, GLUCOSE (GLU SE) 8.7 MMOL/ L AND CREATINE KINASE (CK) 81 U/L. ALL OTHER LABORATORY RESULTS WERE WITHIN NORMAL RANGES. THE CORONAROGRAPHY SHOWED OCCLUSION IN THE PREVIOUSLY IMPLANTED DIAGONAL STENT AND DE NOVO STENOSIS IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND RCA. A 15X3MM NON-BSC DRUG ELUTING STENT WAS IMPLANTED INTO THE RIGHT DESCENDING ARTERY (RAD) AND DIAGONAL STENT RECANALISATION OCCURRED THROUGH BALLOON DILATION. THERE WERE NO COMPLICATIONS AND THE PATIENT WAS DISCHARGED. THE OUTCOME OF THE EVENT WAS RECOVERED/RESOLVED. DUE TO THE PATIENT'S HIGH TENDENCY FOR RESTENOSIS OF THE PROXIMAL LAD . IT WAS RECOMMENDED THAT THE PATIENT CONTINUE CONCOMITANTLY THE CLOPIDOGREL AND THE ASPIRIN FOR 12 MORE MONTHS. READMISSION WAS PLANNED IN 2 MONTHS FOR A PERCUTANEOUS CORONARY INTERVENTION. OPTIMIZATION OF THE PATIENT'S DIABETES THERAPY WAS ALSO RECOMMENDED , CONSIDERING THE HIGH TENDENCY FOR RESTENOSIS. THE PATIENT'S UPDATED MEDICATION THERAPY INCLUDED : METFORMIN, GLIMEPIRIDE, DOXAZOSIN, TELMISARTAN, TRIMETAZIDINE, PANTOPRAZOLE AND ALLOPURINOL. THE (B)(6) 2011 REVASCULARIZATION WAS PLANNED AND INCLUDED REPEAT CORONARY DEXTRA (CD).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TAXUS ELEMENT PACLITAXEL-ELUTING CORONARY STENT SYSTEM | CORONARY DRUG-ELUTING STENT | NIQ | BOSTON SCIENTIFIC - GALWAY | UNK571 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |