BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1904501 · Received November 22, 2010

    Report

    Report Number
    2134265-2010-05027
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 26, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (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).

    Description of Event or Problem · 1

    SAME CASE AS MFR#: 2134265-2010-05028, 2134265-2010-05386. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A PERFORATION OCCURRED. TWO LESIONS WERE BEING TREATED IN THE RIGHT CORONARY ARTERY (RCA). THE LESION LOCATED IN THE MID-DISTAL PORTION WAS 40-60% STENOSED AND THE LESION LOCATED IN THE PROXIMAL PORTION WAS 80% STENOSED. IVUS AND ANGIOGRAPHY WERE PERFORMED. THE PHYSICIAN SUCCESSFULLY DEPLOYED BOTH THE 4.00X16MM (PROXIMAL) AND 4.00X38 (DISTAL) TAXUS LIBERTE STENTS, OVERLAPPING, IN THE RCA. ANGIOGRAPHY SHOWED "TIGHTNESS" WITH THE MID RCA. THE PHYSICIAN WAS CONCERNED ABOUT INSUFFICIENT DEPLOYMENT OF THE STENT. THE PHYSICIAN USED THE STENT DELIVERY BALLOON FROM THE 4.00X16 TAXUS LIBERTE TO POST DILATE, INFLATING TO 20 ATMOSPHERES. THE PATIENT BEGAN TO EXPERIENCE CHEST PAIN. FOLLOW-UP ANGIOGRAPHY IDENTIFIED A PERFORATION OF THE MID RCA. THE PHYSICIAN INFLATED AN UNKNOWN BALLOON TO 14ATMS FOR 15 MINUTES, INTERMITTENTLY RELEASING TO ALLOW FOR DISTAL FLOW, IN ORDER TO TAMPONADE THE PERFORATION. A REDUCTION IN CHEST PAIN AND IMPROVEMENT OF ST ELEVATION WAS NOTED ON EKG. THE PERFORATION WAS TREATED WITH A 3.5X16MM NON-BSC COVERED STENT. THERE WAS STILL EXTRAVASATION OF BLOOD NOTED. A 4.5X20MM NC QUANTUM APEX BALLOON WAS USED TO SEAL THE PERFORATION. AS A RESULT SOME OF THE SMALL PROXIMAL RCA BRANCHES WERE OCCLUDED AND A CLOT DEVELOPED AT THE AREA OF PERFORATION THAT MIGRATED DISTALLY TO THE PDA. SOME IMPROVEMENT OF FLOW WAS ACHIEVED WITH ADENOSINE AND NITROGLYCERINE. FINAL ANGIOGRAPHY REVEALED <10% RESIDUAL STENOSIS WITH TIMI 3 FLOW. POST PROCEDURE ECHOCARDIOGRAM SHOWED NO EVIDENCE OF PERICARDIAL EFFUSION OR GROSS WALL MOTION ABNORMALITIES. THE PATIENT'S STATUS IS OK. MEDICATIONS GIVEN INCLUDED: PLAVIX AND PROTAMINE.

    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 - GALWAY H7493893638400 12800260

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention 6FJR GUIDE CATHETER| 4.00X16MM TAXUS LIBERTE STENT| .014 LUGE GUIDE WIRE