BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2771599 · Received October 4, 2012

    Report

    Report Number
    2134265-2012-06207
    Event Type
    Injury
    Date Received
    October 4, 2012
    Date of Event
    August 8, 2012
    Report Date
    September 5, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATION 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

    (B)(4). SAME CASE AS MDR ID#:2134265-2012-06206. IT WAS REPORTED THAT POST A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, THE PATIENT EXPERIENCED CHEST PAINS, MYOCARDIAL INFARCTION, SHORTNESS OF BREATH AND STENOSIS. IN (B)(6) 2011 DURING THE INDEX PROCEDURE, THE MIDDLE FIRST TARGET LESION WAS LOCATED IN THE SAPHENOUS VEIN GRAFT TO THE FIRST MIDDLE DIAGONAL ARTERY. THE FIRST TARGET LESION WAS TREATED WITH MULTIPLE BALLOON INFLATIONS AND PLACEMENT OF A TAXUS LIBERTE MONORAIL 3.0X38MM STENT. (4.2 ATM FOR 8 SECONDS, 5.3 ATM FOR 9 SECONDS, 9.7 ATM FOR 13 SECONDS, 15.8 ATM FOR 13 SECONDS AND 16 ATM FOR 9 SECONDS) THE SECOND TARGET LESION WAS LOCATED IN THE SAPHENOUS VEIN GRAFT TO THE FIRST DIAGONAL, AORTIC ANASTOMOSIS. THE SECOND TARGET LESION WAS TREATED WITH PLACEMENT OF A TAXUS LIBERTE MONORAIL 3.0X32MM STENT, INFLATED TO 20 ATM FOR 16 SECONDS AND 20 ATM FOR 12 SECONDS. THE PATIENT WAS DISCHARGED AT AN UNKNOWN DATE ON 75MG PLAVIX. IN (B)(6) 2012, THE PATIENT PRESENTED TO THE ER WITH SEVERE CHEST PAIN THAT HAD BEEN INTERMITTENT SINCE THE PREVIOUS EVENING. UPON ARRIVAL TO THE ER, THE PATIENT HAD 4/10 CHEST PAIN. OVERNIGHT, NITRATES WERE ADMINISTERED. THE MORNING OF ADMISSION, THE PATIENT WAS REFRACTORY, BETWEEN 7 & 9 OUT OF 10 IN THE PATIENT'S CHEST, RADIATING TO HIS JAW, ARM, AND DOWN TO HIS HANDS. THE PATIENT WAS EXPERIENCING SHORTNESS OF BREATH WITH MINIMAL RELIEF WITH NITROGLYCERINE. EKG SHOWED NORMAL SINUS RHYTHM (NSR) WITH NON-SPECIFIC ST-T ABNORMALITY IN THE INFEROLATERAL LEADS. THESE CHANGES WERE MINIMALLY MORE EVIDENT THAN PREVIOUSLY. THE PATIENT WAS TAKEN EMERGENTLY TO THE CATH LAB. 85% ULCERATIVE STENOSIS IN THE PROXIMAL VEIN GRAFT TO THE DIAGONAL WAS NOTED. THE FIRST DIAGONAL BRANCH SEGMENT WAS TREATED WITH A 3.5MM-5.5MM 190CM FILTERWIRE; AND PLACEMENT OF A PROMUS ELEMENT 3.00X32MM STENT INFLATED TO 15 ATM FOR 0:28 SECONDS. THE PATIENT'S PAIN RESOLVED WITHIN 1 HOUR OF STENT DEPLOYMENT AND OVERNIGHT THE PATIENT'S SHORTNESS OF BREATH IMPROVED DRAMATICALLY. THE FOLLOWING DAY THE PATIENT WAS DISCHARGED.

    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 UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention