TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Report
- Report Number
- 2134265-2010-05966
- Event Type
- Death
- Date Received
- January 13, 2011
- Date of Event
- April 12, 2010
- Report Date
- December 17, 2010
- Manufacturer
- BOSTON SCIENTIFIC - GALWAY
- Product Code
- NIQ
- PMA / PMN Number
- P030025
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
DEVICE IS 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. 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).
DESCRIBE EVENT OR PROBLEM: UPDATED(B)(4)
IT WAS FURTHER REPORTED THAT THERE WAS TIMI-2 FLOW PRE INDEX PROCEDURE, AND CORE LAB ANALYSIS CONFIRMED PRE TREATMENT STENOSIS TO BE 77%. POST TREATMENT TIMI FLOW WAS 3 AND PER CORE LAB ANALYSIS, RESIDUAL STENOSIS WAS 12%. THE PATIENT WAS DISCHARGED ON NICHISTATE AND BAYASPIRIN.
(B)(4). SAME PATIENT AS MFR ID#: 2134265-2009-03771, 2134265-2009-03772, 2134265-2009-03773. SAME CASE AS MFR ID#: 2134265-2010-05967, 2134265-2010-05968. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, PATIENT DEATH OCCURRED. (B)(6) 2007: CARDIAC CATHETERIZATION CONFIRMED A 95% STENOSED AND 15MM LONG LESION LOCATED IN THE DISTAL LEFT CIRCUMFLEX CORONARY ARTERY (LCX) WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. IT WAS REPORTED TO BE IN STENT RESTENOSIS BUT THE STENT TYPE WAS UNKNOWN. THE LESION WAS PREDILATED WITH A 3.0X15MM BALLOON AT 20ATM AND A 3.0X20MM TAXUS EXPRESS2 WAS IMPLANTED AT 22ATM. POST DILATION WAS PERFORMED WITH THE PRE-DILATION BALLOON AT 22ATM RESULTING IN 0% RESIDUAL STENOSIS AND TIMI-3 FLOW WAS MAINTAINED. 3000U OF HEPARIN WAS ADMINISTERED. THE PATIENT WAS DISCHARGED THE NEXT DAY. SILENT ISCHEMIA WAS CONFIRMED AT DISCHARGE AND AT THE 1 MONTH FOLLOW UP VISIT. (B)(6) 2008: DUE TO CHEST DISCOMFORT AND RESPIRATORY DISCOMFORT, THE PATIENT WAS TAKEN BY AMBULANCE TO THE HOSPITAL, AND WAS HOSPITALIZED WITH HEART FAILURE. WHILE HOSPITALIZED, THE PATIENT WAS INTUBATED MULTIPLE TIMES. IT WAS NOTED BY HER PHYSICIAN THAT SHE HAS AN OLD MYOCARDIAL INFARCT AND HAS OFTEN HAD CARDIAC FAILURE. SHE HAD CHRONIC RENAL FAILURE AT THAT TIME AND WAS UNDERGOING DIALYSIS. SHE ALSO EXPERIENCED A FEVER DUE TO CHOLEDOCHOLITHIASIS. (B)(6) 2008: CARDIAC CATHETERIZATION REVEALED A NEW 75% STENOSED LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA). IT WAS TREATED WITH PLACEMENT OF A 2.5X20MM AND 2.5X12MM TAXUS EXPRESS2 STENTS RESULTING IN 0% RESIDUAL STENOSIS AND TIMI-3 FLOW. THE PATIENT EXPERIENCED ANEMIA AND CARDIAC FAILURE THE MONTH FOLLOWING THE PROCEDURE, BUT WAS NOT RELATED TO THE TAXUS STENTS. THE PATIENT WAS INTUBATED AND DIALYSIS WAS PERFORMED. (B)(6) 2008: DUE TO CHEST PAIN AND BACK PAIN, THE PATIENT HAD A CT SCAN WHICH REVEALED A DISSECTING ANEURYSM OF THE AORTA. PER THE PHYSICIAN, THIS WAS NOT RELATED TO THE TAXUS STENTS. (B)(6) 2008: THE PATIENT WAS DISCHARGED. SHE WAS HOSPITALIZED FROM (B)(6) 2008 TO (B)(6) 2008. IT WAS NOTED THAT SHE STILL HAD SILENT ISCHEMIA. (B)(6) 2010: THE PATIENT EXPERIENCED CARDIO-RESPIRATORY ARREST AND WAS TAKEN TO THE HOSPITAL. HOWEVER, THE PATIENT DIED THE SAME DAY.
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 | H7493897020300 | 9744291 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Death |