BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1904599 · Received November 22, 2010

    Report

    Report Number
    2134265-2010-05325
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 29, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A TAXUS LIBERTE MONORAIL STENT DELIVERY SYSTEM (SDS) IN TWO PIECES. IT WAS DETERMINED THAT THE HYPOTUBE WAS BROKEN 15CM. FROM THE STRAIN RELIEF. MICROSCOPIC EXAMINATION OF THE MATERIAL SURROUNDING THE HYPOTUBE BREAK DID NOT REVEAL ANY INHERENT DEFICIENCIES. THE RETURNED CATHETER WAS VISUALLY AND TACTFULLY EXAMINED ALONG THE ENTIRE LENGTH OF SHAFT AND NO OTHER DAMAGE WAS FOUND. THE DISTAL END OF THE SDS WAS INSPECTED UNDER MAGNIFICATION AND FOUND TIP AND STENT DAMAGE. IT WAS DETERMINED THAT THREE STRUTS WERE DAMAGED AT THE PROXIMAL END OF THE STENT AND EXTENDING BACK UP TO 180 DEGREES. THE UNDAMAGED PORTION OF THE RETURNED STENT MEETS THE APPLICABLE SPECIFICATION FOR OUTER DIAMETER. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, A SHAFT FRACTURE OCCURRED. A 2.75X16MM TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO AN UNKNOWN TARGET LESION. WHILE ATTEMPTING TO PLACE THE DEVICE IN THE LESION, THE CATHETER SHAFT OF THE SDS BROKE IN HALF INSIDE THE GUIDE CATHETER. THEY USED ANOTHER OF THE SAME TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THERE WERE TWO TARGET LESIONS. THE FIRST WAS 15MM LONG X 4.5MM WITH 60% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA) WITH "MARKED TORTUOUSITY". THE SECOND WAS 12MM LONG X 3MM WITH 99% STENOSIS IN THE DISTAL RCA. THE LESION WAS PREDILATED AND A BUDDY WIRE WAS USED. WHILE ATTEMPTING TO ADVANCE THE 2.75X16MM TAXUS LIBERTE STENT DELIVERY SYSTEM, RESISTANCE AND FRICTION WAS ENCOUNTERED. A SHAFT BREAK OCCURRED 23CM FROM THE PROXIMAL WIRE PORT, AND THE BROKEN PORTION WAS HELD COMPLETELY WITHIN THE GUIDE CATHETER AND WAS ABLE TO BE RETRIEVED BY REMOVING THE DEVICE CAREFULLY WITH THE BUDDY WIRE WRAPPED AROUND IT FOR SUPPORT. ONCE REMOVED, EXAMINATION REVEALED THAT THE STENT WAS HELD SECURELY ON THE BALLOON, BUT THAT A STENT STRUT ON THE PROXIMAL END OF THE BALLOON WAS BENT UPWARDS. THE FINAL OUTCOME AFTER TREATMENT WAS 60% STENOSIS IN THE MID RCA AND 0% STENOSIS OF THE DISTAL RCA.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THERE WERE TWO TARGET LESIONS. THE FIRST WAS 15MM LONG X 4.5MM WITH 60% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA) WITH "MARKED TORTUOUSITY." THE SECOND WAS 12MM LONG X 3MM WITH 99% STENOSIS IN THE DISTAL RCA. THE LESION WAS PREDILATED AND A BUDDY WIRE WAS USED. WHILE ATTEMPTING TO ADVANCE THE 2.75X16MM TAXUS LIBERTE STENT DELIVERY SYSTEM, RESISTANCE AND FRICTION WAS ENCOUNTERED. A SHAFT BREAK OCCURRED 23CM FROM THE PROXIMAL WIRE PORT, AND THE BROKEN PORTION WAS HELD COMPLETELY WITHIN THE GUIDE CATHETER AND WAS ABLE TO BE RETRIEVED BY REMOVING THE DEVICE CAREFULLY WITH THE BUDDY WIRE WRAPPED AROUND IT FOR SUPPORT. ONCE REMOVED, EXAMINATION REVEALED THAT THE STENT WAS HELD SECURELY ON THE BALLOON, BUT THAT A STENT STRUT ON THE PROXIMAL END OF THE BALLOON WAS BENT UPWARDS. THE FINAL OUTCOME AFTER TREATMENT WAS 60% STENOSIS IN THE MID RCA AND 0% STENOSIS OF THE DISTAL RCA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893616270 13436981

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR SPRINTER RX 1.5 X6MM| 3 PROWATER 180 CM WIRES| QUANTUM RX 3.0X12MM| 7F HOCKEY STICK SH GUIDE| QUANTUM RX 2.5X12MM