BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2212274 · Received August 15, 2011

    Report

    Report Number
    2134265-2011-03352
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 21, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. 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

    IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, STENT THROMBOSIS OCCURRED. INDICATION FOR CATHETERIZATION WAS ACUTE MYOCARDIAL INFARCTION (AMI) OF THE ANTEROLATERAL WALL. ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 6FR FL4 RUNWAY GUIDE CATHETER ENGAGED THE TARGET LESION AND A 0.014X300CM HTF FLOPPY EXTRA SUPPORT GUIDE WIRE WAS ADVANCED. A 2.5X15MM APEX BALLOON CATHETER WAS ADVANCED AND THE LESION WAS PREDILATED TO THE FOLLOWING INFLATIONS: 6ATMS/12SEC, 6ATMS/20SEC, 6ATMS/30SEC AND 14ATMS/15SEC. A 2.75X28MM ION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND THE STENT WAS DEPLOYED AT 11ATMS/15SEC AND THE DELIVERY BALLOON WAS INFLATED AGAIN TO 10ATMS/15SEC. THE PATIENT WAS ADMINISTERED HEPARIN AND EFFIENT DURING THE INITIAL CASE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DOING WELL. 15 DAYS LATER THE PATIENT RETURNED FOR A SCHEDULED PROCEDURE FOR THE RCA. STENT THROMBOSIS WAS NOTED IN THE LAD. A 1.5X12MM APEX FLEX BALLOON WAS ADVANCED AND INFLATED IN THE CIRCUMFLEX. IT WAS ADVANCED TO THE LAD AND INFLATED THREE TIMES TO 10ATMS FOR 4-10SEC. THE PATIENT EXPERIENCED PAIN IN HER RIGHT HAND. THE PHYSICIAN ADVANCED A 3.0X8MM APEX BALLOON CATHETER TO THE LAD AND THE BALLOON WAS INFLATED FOUR TIMES TO 12 ATMS FOR 6-10 SECONDS. PATIENT STATES THAT THE RIGHT HAND PAIN WAS RELIEVED. NEXT, A 3.0X12MM PROMUS SDS WAS ADVANCED AND THE STENT WAS DEPLOYED AT 9ATMS/12 SECONDS. THE DELIVERY BALLOON WAS USED TO POST DILATE THE STENT AT 12-14ATMS. A 2.5X15MM NC QUANTUM APEX BALLOON WAS ADVANCED TO THE LAD AND INFLATED THREE TIMES TO 4-6ATMS. A 3.0X12MM NC QUANTUM APEX WAS ALSO ADVANCED TO THE LAD AND WAS INFLATED THREE TIMES BETWEEN 14 AND 20ATMS. NEXT, A 2.5X12MM PROMUS STENT WAS DEPLOYED AT 6ATMS IN THE LAD AND WAS DILATED TO 8ATMS WITH THE DELIVERY BALLOON. A 3.25X12MM NC QUANTUM APEX BALLOON WAS ADVANCED TO POST DILATE AND WAS INFLATED UP TO 17ATMS. LASTLY, A 2.75X18MM PROMUS SDS WAS ADVANCED TO THE LAD AND THE STENT WAS DEPLOYED AT 11ATMS AND POST DILATED USING A 3.25X12MM NC QUANTUM APEX BALLOON INFLATED UP TO 18ATMS. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902428270 0014091165

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention ENCORE INFLATION DEVICE| HTF FLOPPY EXTRA SUPPORT GUIDE WIRE| 6FR FL4 RUNWAY GUIDE CATHETER| 6FRX10CM PINNACLE INTRODUCER SHEATH| 2.5X15MM APEX BALLOON CATHETER