BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1830335 · Received September 10, 2010

    Report

    Report Number
    2134265-2010-04135
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    June 9, 2010
    Report Date
    August 16, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4). IF IMPLANTED, GIVE DATE: (B)(6) 2004. 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).

    Description of Event or Problem · 1

    (B)(4) CLINICAL TRIAL. SAME CASE AS MFR ID#: 2134265-2010-04133, 2134265-2010-04134, 2134265-2010-04137. SAME PATIENT AS MFR ID#: 2134265-2010-04130, 2134265-2010-04131, 2134265-2010-04132. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED STABLE ANGINA AND RESTENOSIS. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). IT WAS TREATED WITH PLACEMENT OF 1 UNKNOWN SIZE TAXUS EXPRESS2 STENT. FOUR YEARS LATER, THE PATIENT PRESENTED WITH A 95% STENOSED COMPLEX LESION IN THE MID RCA. IT WAS TREATED WITH PLACEMENT OF A 3.0X28MM TAXUS EXPRESS2 STENT WITH GOOD ANGIOGRAPHIC RESULTS. AT 590 DAYS POST THE SECOND STENT DEPLOYMENT, THE PATIENT EXPERIENCED AN ST ELEVATION MYOCARDIAL INFARCTION WITH A PEAK CK OF 632, TROPONIN OF 14.5 AND DEVELOPMENT OF SMALL INFERIOR Q-WAVES. CARDIAC CATHETERIZATION REVEALED TIGHT MID RCA STENOSIS AT THE LEVEL OF THE RIGHT VENTRICULAR BRANCH WITH TIMI-1 FLOW AND 80% STENOSIS IN THE DISTAL RCA. IT WAS TREATED WITH PLACEMENT AN UNKNOWN SIZE TAXUS LIBERTE STENT AND A 3.0X16MM TAXUS LIBERTE STENT. AT 145 DAYS LATER, DUE TO STABLE ANGINA, THE PATIENT UNDERWENT CARDIAC CATHETERIZATION WHICH REVEALED RESTENOSIS OF THE MID RCA. THE PATIENT REPORTED COMPLIANCE WITH MEDICATION. THE PATIENT WAS ADMINISTERED PLAVIX, IV ANGIOMAX, AND INTRACORONARY CARDENE AND NITROGLYCERINE. A NON-BSC GUIDE WIRE WAS USED TO CROSS THE LESION FOLLOWED BY A NON-BSC 2.5X12MM BALLOON CATHETER WHICH WAS INFLATED ONE TIME TO 14ATM. ANGIOGRAPHY CONFIRMED TIMI-3 FLOW WITH RESIDUAL STENOSIS AND NO DISSECTION. AN INITIAL ATTEMPT WAS MADE TO PLACE A 2.75X23MM PROMUS STENT, BUT DUE TO VESSEL TORTUOUSITY AND "STENT/WIRE BIAS," IT WAS UNSUCCESSFUL AND THE DEVICE WAS WITHDRAWN. A NON-BSC FLOPPY GUIDE WIRE WAS ADVANCED ACROSS THE LESION AND THE SAME PROMUS STENT ADVANCED A SECOND TIME. THE STENT WAS DEPLOYED AT 16ATM. ANGIOGRAPHY CONFIRMED TIMI-3 FLOW WITH MILD STENT UNDEREXPANSION AND NO EDGE DISSECTION. A 3.25X8MM QUANTUM APEX BALLOON WAS ADVANCED IN POST DILATED THE AREA THREE TIMES TO A MAXIMUM OF 24ATM. ANGIOGRAPHY CONFIRMED TIMI-3 FLOW WITH ADEQUATE STENT EXPANSION AND NO EDGE DISSECTION. INTRAVASCULAR ULTRASOUND (IVUS) REVEALED ADEQUATE STENT APPOSITION BUT MILD STENT UNDER EXPANSION AT THE DISTAL EDGE AND NOTED MINIMAL LUMINAL DIAMETER THAT WAS "QUITE SMALL." A QUANTUM NC APEX 3.5X8MM BALLOON CATHETER WAS PLACED ACROSS THE STENTED REGION AND INFLATED 3 TIMES TO A MAXIMUM OF 18ATM. ANGIOGRAPHY CONFIRMED TIMI-3 FLOW WITH ADEQUATE STENT EXPANSION WITH NO EDGE DISSECTION. REPEAT IVUS REVEALED ADEQUATE STENT APPOSITION AND IMPROVED EXPANSION IN THE DISTAL WAIST AREA. IT WAS REPORTED THAT THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT CHEST DISCOMFORT AND THE PROCEDURE WAS CLOSED. THE PATIENT WAS DISCHARGED 1 DAY LATER. AT 33 DAYS POST DISCHARGE, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH RECURRENT CHEST PAIN. ECG WAS NORMAL AND TROPONIN WAS NEGATIVE. THE NEXT DAY, THE PATIENT WAS READMITTED FOR NAUSEA, VOMITING, CHEST PAIN, AN ACUTE INFERIOR POSTERIOR WALL WITH ST ELEVATION MYOCARDIAL INFARCTION AND ECG CHANGES. THE CHEST PAIN WAS REPORTED TO HAVE STARTED 4 DAYS EARLIER AND WAS DESCRIBED AS A PULLED MUSCLE SENSATION ACROSS HIS CHEST RADIATING TO BOTH SHOULDERS INTO HIS BACK. THE DAY OF ADMIT, HE DESCRIBED AN ONSET OF THE "WORST CHEST PAIN HE HAS HAD," FOR WHICH HE TOOK NITROGLYCERIN AND SUMMONED EMERGENCY MEDICAL SERVICES. HE WAS TRANSFERRED TO THE CARDIOVASCULAR LAB AND WAS REPORTED TO HAVE ONGOING CHEST PAIN THAT WAS RATED AT 10 OUT OF 10 WITH NO PALPITATION, PRESYNCOPE OR SYNCOPE. THE PATIENT REPORTS COMPLIANCE WITH ALL OF HIS MEDICATIONS INCLUDING PLAVIX AND ASPIRIN. CARDIAC CATHETERIZATION REVEALED THE PRESENCE OF AN ACUTE IN-STENT THROMBOSIS IN THE RCA. LVEF WAS REPORTED TO BE 71%. INTRACORONARY AND IV REOPRO, IV ANGIOMAX AS WELL AS INTRACORONARY CARDENE AND NITROGLYCERINE WERE ADMINISTERED. ANGIOGRAPHY CONFIRMED THAT THE RCA IS STENTED "FROM BEGINNING TO END," NOT INCLUDING THE OSTIUM AND THAT THE POSTERIOR DESCENDING ARTERY IS JAILED. PER THE TREATING PHYSICIAN, THE PROBLEM APPEARS TO BE THE LAST-PLACED STENT WHERE THERE IS A DOUBLE DENSITY OF STENTS IN THE MID VESSEL THAT IS THROMBOSED AND THAT THE THROMBUS HAS PROPAGATED BACKWARDS. THE VESSEL WAS 100% OCCLUDED WITH TIMI-0 FLOW. BALLOON ANGIOPLASTY WAS PERFORMED USING A 3.0X20MM NON-COMPLIANT QUANTUM AT 20ATM FOLLOWED BY A 3.5MM QUANTUM WHICH WAS USED IN THE STENT LOCATED IN THE BEND IN THE MID RCA. FINAL RESULTS INCLUDED 0% STENOSIS, TIMI-3 FLOW AND A FINAL VESSEL DIAMETER OF 3.6MM. THE EVENT WAS SAID TO BE RESOLVED THE SAME DAY. PEAK TROPONIN WAS REPORTED TO BE IN THE "20 RANGE" AND THE PATIENT REPORTED SOME VERY MINIMAL BILATERAL SHOULDER DISCOMFORT 1 DAY POST PROCEDURE WHICH RESOLVED WITH NO EKG CHANGES. THE PATIENT WAS DISCHARGED 2 DAYS LATER. THE DAY OF DISCHARGE THE PATIENT WAS REPORTED TO BE PAIN FREE. IT IS THE OPINION OF THE PHYSICIAN THAT THE EVENT IS POSSIBLY RELATED TO THE PROMUS STUDY DEVICE. THE PHYSICIAN COMMENTED THAT THE PATIENT MAY BE RESISTANT TO PLAVIX AND AS SUCH DISCONTINUED THE PLAVIX AND STARTED HIM ON EFFIENT ALONG WITH CONTINUING ASPIRIN. FURTHERMORE, THE PATIENT REPORTED TAKING A SUPPLEMENT AT HOME THAT HAS OVER 12 DIFFERENT TYPES OF HERBAL MEDICATIONS IN IT. IT IS THE OPINION OF THE PHYSICIAN THAT ONE OF THESE COULD BE EFFECTING THE METABOLISM OF THE CLOPIDOGREL OR ASPIRIN. AS A RESULT HE HAS RECOMMENDED THAT HE DISCONTINUE THE SUPPLEMENT.

    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 50 YR Hospitalization| R