TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Report
- Report Number
- 2134265-2010-04451
- Event Type
- Injury
- Date Received
- September 23, 2010
- Date of Event
- July 19, 2010
- Report Date
- August 30, 2010
- Manufacturer
- BOSTON SCIENTIFIC - MAPLE GROVE
- Product Code
- NIQ
- PMA / PMN Number
- P030025
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
DEVICE IS COMBINATION PRODUCT. (B)(4). IF IMPLANTED, GIVE DATE: 2005. (B)(4). 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)
(B)(4).
(B)(4). SAME CASE AS MFR ID #: 2134265-2010-04452, 2134265-2010-04450, 2134265-2010-04453. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, POOR STENT EXPANSION OCCURRED AND THAT POST A STENTING TREATMENT PROCEDURE, IN STENT RESTENOSIS OCCURRED. IN 2005, DUE TO CHEST PAIN AND INFEROLATERAL ISCHEMIA, THE PATIENT UNDERWENT CARDIAC CATHETERIZATION AND HAD 3 UNKNOWN SIZE TAXUS EXPRESS2 STENTS IMPLANTED IN THE LEFT CIRCUMFLEX CORONARY ARTERY (LCX) DUE TO SIGNIFICANT DIFFUSE STENOSIS. FIVE YEARS LATER, DUE TO EXERTIONAL DYSPNEA AND CHEST DISCOMFORT, THE PATIENT UNDERWENT CARDIAC CATHETERIZATION. ACCESS WAS GAINED VIA THE RIGHT FEMORAL ARTERY. ANGIOGRAPHY CONFIRMED A 90-95% STENOSED AND 10MM LONG LESION AT THE ORIGIN OF THE LEFT ANTERIOR DESCENDING CORONARY ARTERY (LCX) WITH A REFERENCE VESSEL DIAMETER OF 3.5MM AND 99.9% STENOSIS OF THE DISTAL SEGMENT PAST PREVIOUSLY PLACED TAXUS EXPRESS2 STENTS. FOLLOWING ANGIOGRAPHY, A CHOICE FLOPPY WIRE WAS ADVANCED, BUT IT WAS UNABLE TO CROSS THE DISTAL LESION. IT WAS EXCHANGED TO A NON-BSC GUIDE WIRE. IT ALSO WAS INITIALLY UNABLE TO CROSS THE DISTAL LESION. A NON-COMPLIANT 3.0MM QUANTUM MAVERICK BALLOON WAS ADVANCED AND THE PROXIMAL LESION WAS DILATED. THE DEFLATED BALLOON WAS THEN ADVANCED DOWN THE VESSEL TO PROVIDE SUPPORT FOR THE DISTAL ASPECT OF THE WIRE, AND WITH THIS THE NON BSC GUIDE WIRE WAS ABLE TO CROSS THE CRITICAL DISTAL STENOSIS INTO THE UPPER LIMB OF THE TRIFURCATION. THE QUANTUM MAVERICK BALLOON WAS REMOVED AND A 1.5MM APEX BALLOON WAS ADVANCED AND USED TO PREDILATE THE DISTAL LESION. IT WAS THEN EXCHANGED FOR A 2.5MM NON-COMPLIANT QUANTUM HIGH PRESSURE BALLOON. SEVERAL HIGH PRESSURE INFLATIONS WERE COMPLETED ACROSS THE DISTAL LESION. SUBSEQUENT ANGIOGRAPHY CONFIRMED THE DISTAL LESION TO BE NEARLY 100% PATENT WITH NO INTIMAL DISRUPTION AND WITH GOOD FLOW TO ALL 3 BRANCHES OF THE TRIFURCATION. INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED TO THE PROXIMAL LESION AND REVEALED THE PROXIMAL ENDS OF THE 3 PREVIOUSLY PLACED TAXUS EXPRESS2 STENTS WERE QUITE COMPRESSED AND UNDER EXPANDED. THERE WAS NOTED TO BE SEVERE OSTIAL LCX STENOSIS WITH EXTENDED INTO THE LEFT MAIN BIFURCATION. THE OSTIAL TARGET LESION WAS TREATED WITH HIGH PRESSURE INFLATIONS USING A NON-COMPLIANT QUANTUM BALLOON IN ORDER TO FURTHER EXPAND THE PREVIOUSLY PLACED UNDER DEPLOYED STENTS AND THE PROXIMAL LESION. A 3.5X12MM TAXUS LIBERTE STENT WAS THEN ADVANCED AND POSITIONED TO EXTEND INTO THE DISTAL LEFT MAIN BUT ALSO TO COVER THE LCX OSTIAL STENOSIS. THE STENT WAS DEPLOYED AT 18ATM FOLLOWED BY AN ADDITIONAL INFLATION USING THE STENT BALLOON AT 18ATM. THE INITIAL RESULTS WERE FAVORABLE. HOWEVER, WHILE FOLLOW UP IVUS SHOWED OVERALL FAVORABLE RESULTS WITH MARKED IMPROVEMENT, IT ALSO REVEALED THAT THE PROXIMAL ASPECT OF THE TAXUS LIBERTE STENT APPEARED SLIGHTLY UNDER DEPLOYED. THE PREVIOUSLY UTILIZED NON COMPLIANT QUANTUM BALLOON WAS ADVANCED AND USED TO POST DILATE THE DISTAL ASPECT OF THE STENT AND THE DISTAL OVERLAP INTO THE PRIOR STENTS AND THROUGH THE BODY OF THE STENT. A SHORT 4.0MM NON COMPLIANT QUANTUM BALLOON WAS THEN ADVANCED AND CARRIED OUT SEVERAL HIGH PRESSURE INFLATIONS FROM THE PROXIMAL END OF THE STENT THROUGH THE MID PORTION OF THE STENT AS IT EXTENDED INTO THE ORIGIN OF THE LCX. FOLLOW UP ANGIOGRAPHY CONFIRMED THE VESSEL TO BE 100% PATENT WITH EXCELLENT ANTEGRADE FLOW. THE DISTAL LESION ALSO REMAINED WIDELY PATENT. THE PATIENT WAS DISCHARGED 1 DAY LATER ON ASPIRIN AND PRASUGREL. ONE MONTH LATER, THE PATENT PRESENTED TO THE EMERGENCY ROOM WITH COMPLAINTS OF CHEST PAIN, FATIGUE AND SHORTNESS OF BREATH WITH EXERTION, HEADACHES AND DIZZINESS. HE REPORTS THAT SINCE HIS LAST PROCEDURE, HE HAS NEVER BEEN COMPLETELY PAIN FREE. AN EKG SHOWED CHRONIC MINOR ST-SEGMENT ABNORMALITIES AND SIGNIFICANT ST-SEGMENT DEPRESSION AND LATERAL PRECORDIAL IN LIMB LEADS. HE ALSO IS REPORTED TO HAVE MILD ELEVATION OF TROPONIN. THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION WHICH REVEALED THE PREVIOUSLY TREATED VESSEL WITH STENTS EXTENDING FROM THE DISTAL LEFT MAIN INTO THE PROXIMAL LCX THAT IS WIDELY PATENT AND A LONG STENTED SEGMENT FROM THE PROXIMAL LCX TO THE SECOND OM THAT IS ALSO WIDELY PATENT. BEYOND THE STENTED SEGMENT IS A 99% STENOSED LESION AFFECTING THE DISTAL TRIFURCATION WITH TIMI-1 FLOW. THOUGH THE STENTS REPORTED TO BE PATENT, THE PHYSICIAN HAS COMMENTED THAT IN HIS OPINION, THE PATIENT MAY HAVE HAD A RESTENOTIC EVENT INVOLVING THE PREVIOUSLY PLACED TAXUS EXPRESS2 STENTS. THE PATIENT WAS GIVEN ANGIOMAX AND THE LESION WAS CROSSED WITH A NON BSC GUIDE WIRE AND A CHOICE EXTRA SUPPORT GUIDE WIRE. A 2.X012MM MAVERICK BALLOON WAS ADVANCED TO THE LESION AND INFLATED TO 6ATM FOR 30 SECONDS. THE BALLOON WAS ALSO ADVANCED TO THE SECOND OM BRANCH AND INFLATED TO 6ATM FOR 60 SECONDS. A 2.25X16MM TAXUS LIBERTE STENT WAS THEN ADVANCED AND DEPLOYED AT 12ATM OVERLAPPING DISTALLY WITH THE PREVIOUS STENTED SEGMENT. THE STENT BALLOON WAS THEN PULLED BACK SLIGHTLY AND INFLATED A SECOND TIME TO 18ATM RESULTING IN 0% STENOSIS AND EXCELLENT ANGIOGRAPHIC RESULTS. TIMI FLOW IMPROVED TO "3" IN ALL 3 SUBDIVISIONS. THE PATIENT WAS DISCHARGED 4 DAYS LATER.
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 - MAPLE GROVE | UNK432 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Hospitalization| R | 3.0MM QUANTUM BALLOON| 2.5MM QUANTUM BALLOON| QUANTUM BALLOON| 3.5X12MM TAXUS LIBERTE STENT| 2 TAXUS EXPRESS2 STENTS| 1.5MM APEX BALLOON| LUGE GUIDE WIRE |