BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 5944973 · Received September 12, 2016

    Report

    Report Number
    2024168-2016-06039
    Event Type
    Injury
    Date Received
    September 12, 2016
    Date of Event
    August 23, 2016
    Report Date
    September 27, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL AND FUNCTIONAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE BALLOON RUPTURE WAS NOT CONFIRMED; HOWEVER, THE INNER MEMBER WAS NOTED TO BE SEPARATED WHICH IS LIKELY WHAT WAS PERCEIVED AS THE BALLOON RUPTURE. THE FAILURE TO DEPLOY WAS CONFIRMED. THE INFLATION ISSUE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT DUE TO THE CONDITION OF THE RETURNED DEVICE. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE NOTED INNER MEMBER SEPARATION; HOWEVER, THE INFLATION ISSUES, FAILURE TO DEPLOY THE STENT, AND PATIENT EFFECT APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER SIMILAR INCIDENTS FROM THIS LOT. THE XIENCE ALPINE INSTRUCTIONS FOR USE (IFU) STATES TO PREPARE THE DEVICE BY REMOVING AIR FROM THE SYSTEM. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: GUIDE WIRE: SION,SION BLUE; GUIDE CATH: ASAHI HYPERION. (B)(4). THE DEVICE WAS RECEIVED. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A NON-CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. FOLLOWING PRE-DILATION WITH A NON-ABBOTT BALLOON CATHETER, A 2.75X23MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION WITHOUT RESISTANCE. AN ATTEMPT WAS MADE TO DEPLOY THE STENT; HOWEVER, THE PRESSURE INDICATION OF THE INDEFLATOR DID NOT INCREASE AND THE BALLOON DID NOT APPEAR TO BE INFLATED ON ANGIOGRAPHY. AIR WAS OBSERVED TO BE LEAKING FROM THE BALLOON ON ANGIOGRAPHY WHICH RESULTED IN AIR BEING INTRODUCED INTO THE ANATOMY. THE SDS WAS REMOVED WITH THE STENT INTACT. THE PROCEDURE WAS ABORTED UNTIL THE PATIENT STABILIZED. AFTER 30 MINUTES AND CONFIRMING NO AIR WAS IN THE VESSEL THE PROCEDURE WAS RESUMED. THE PROCEDURE WAS COMPLETED SUCCESSFUL WITH THE PLACEMENT OF ANOTHER NON-ABBOTT STENT. THE PHYSICIAN FURTHER COMMENTED THAT HE IS UNSURE IF AIR ASPIRATION WAS DONE PRIOR TO PRESSURIZATION OF THE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596617 XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 6020341

    Patients

    Seq Age Sex Outcome Treatment
    1 Other