TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Report
- Report Number
- 2134265-2010-03037
- Event Type
- Death
- Date Received
- July 15, 2010
- Date of Event
- December 28, 2009
- Report Date
- June 17, 2010
- Manufacturer
- BOSTON SCIENTIFIC - GALWAY
- Product Code
- NIQ
- PMA / PMN Number
- P030025
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
ANY EVALUATION OF THE INCIDENT DESCRIBED IN THE MEDICAL DEVICE REPORT BY THE ATTENDING PHYSICIAN, SURGEON, HOSPITAL REPRESENTATIVE OR THE HEALTH CARE PROFESSIONAL. THE PHYSICIAN STATED THAT THE PATIENT DIED AT A DIFFERENT FACILITY SO DID NOT KNOW THE CAUSE OF DEATH. "HOWEVER, THE PATIENT WAS A DIALYSIS PATIENT; VALUE OF K+ WAS 7.8MEQ/L, WHICH MIGHT BE RELATED TO THE DEATH." THE CLINICAL LABORATORY TEST RESULTS ARE NOT AVAILABLE. THE PRIMARY AND SECONDARY CAUSES OF DEATH AS DESCRIBED IN THE AUTOPSY REPORT, IF AN AUTOPSY WAS PERFORMED. RESPONSE: WE WERE INFORMED THAT NO AUTOPSY WAS PERFORMED. (B)(4)
(B)(4)
DEVICE EVALUATED BY MANUFACTURER:IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.(B) (4)
IT WAS FURTHER REPORTED THAT A NON BSC DRUG ELUTING STENT WAS IMPLANTED IN THE MID RIGHT CORONARY ARTERY (RCA), RIGHT POSTERIOR DESCENDING ARTERY (R-PDA) AND RIGHT ATRIOVENTRICULAR BRANCH ARTERY (R-PAV) IN 2005. IN-STENT RESTENOSIS OCCURRED IN 2007 IN THE R-PDA AND R-PAV AND WAS TREATED WITH THE IMPLANTATION OF A TAXUS EXPRESS2 STENT IN BOTH VESSELS.
IT WAS FURTHER REPORTED THAT THE IN-STENT RESTENOSED LESION WITH REFERENCE VESSEL DIAMETER OF 3.00MM, LENGTH OF 12.0MM, AND 90% STENOSIS LOCATED IN THE RIGHT ATRIOVENTRICULAR BRANCH WAS TREATED WITH PRE-DILATATION AND DEPLOYMENT OF THE TAXUS EXPRESS2 STENT. POST-DILATION WAS NOT PERFORMED. RESIDUAL STENOSIS WAS 0% AND TIMI-3 FLOW KEPT THROUGH THE PROCEDURE. THE IN-STENT RESTENOSED LESION WITH REFERENCE VESSEL DIAMETER OF 3.00MM, LENGTH OF 14.8MM, AND 100% STENOSIS LOCATED IN RIGHT ATRIOVENTRICULAR BRANCH WAS TREATED WITH PRE-DILATATION AND DEPLOYMENT OF THE TAXUS EXPRESS2 STENT. POST-DILATION WAS NOT PERFORMED. RESIDUAL STENOSIS WAS 0% AND TIMI FLOW IMPROVED FROM 0 TO 3 THROUGH THE PROCEDURE. THE PATIENT WAS DISCHARGED WITHOUT COMPLICATIONS THE NEXT DAY ON BAYASPIRIN AND PANALDINE. THE PATIENT WAS DIAGNOSED WITH SUDDEN DEATH AND TRANSFERRED IN A CONDITION OF CARDIOPULMONARY ARREST TO A HOSPITAL WHICH WAS NOT THE SITE HOSPITAL. IT WAS REPORTED THAT VENTRICULAR TACHYCARDIA MIGHT HAVE OCCURRED, BECAUSE THE POTASSIUM CONCENTRATION IN THE BLOOD WAS 7.8. AUTOPSY WAS NOT PERFORMED.
(B) (4). SAME CASE AS 2134265-2010-03036. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING PROCEDURE, THE PATIENT EXPIRED. THE LESION BEING TREATED WAS A PORTION OF THE RIGHT POSTERIOR DESCENDING ARTERY (RPDA) AND THE RIGHT ATRIOVENTRICULAR BRANCH. THE PHYSICIAN IMPLANTED TWO (3.00X12MM AND 3.00X16MM) TAXUS EXPRESS STENTS IN THE TARGET LESION. AT 2 YEARS LATER, THE PATIENT DIED SUDDENLY. THE PATIENT WAS FOUND TO HAVE FALLEN DOWN AT HOME BY HIS FAMILY, AND WAS TRANSFERRED TO ANOTHER FACILITY. THE PATIENT EXPIRED AT THE OTHER FACILITY. THE PHYSICIAN DIDN'T KNOW CAUSE OF DEATH, AND IN THE OPINION OF THE PHYSICIAN, THE RELATIONSHIP BETWEEN THE TAXUS STENT AND THE PATIENT'S DEATH IS "POSSIBLE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM | CORONARY DRUG-ELUTING STENT | NIQ | BOSTON SCIENTIFIC - GALWAY | H7493897016300 | 11045612 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Death | TAXUS EXP2- 8.8PCT (MRUS) - 3.00X12MM |