BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2882401 · Received December 20, 2012

    Report

    Report Number
    2024168-2012-08211
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. GUIDE WIRE: SION, XT-R, GUIDE CATHETER: PROFIT JR3.5SH 6F. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSED DIFFUSE LESION (40 MM) LOCATED IN THE MID AND DISTAL RIGHT CORONARY ARTERY (RCA) THAT HAD MODERATE CALCIFICATION AND MILD TORTUOSITY. AFTER PRE-DILATATION WAS PERFORMED, THE XIENCE PRIME STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER, THE SDS WOULD NOT CROSS. WHEN THE SDS WAS RETRACTED, THE STENT IMPLANT DISLODGED OFF THE BALLOON AND REMAINED AT THE MID RCA. THE STENT IMPLANT WAS STILL ON THE GUIDE WIRE AND A NON-ABBOTT BALLOON WAS DELIVERED INTO THE STENT AND INFLATED TO SUCCESSFULLY REMOVE THE DISLODGED STENT IMPLANT FROM THE PATIENT'S ANATOMY. THE PROCEDURE WAS ENDED WITHOUT FURTHER TREATMENT. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUSLY FILED MEDWATCH ADDITIONAL INFORMATION RECEIVED AS FOLLOWS: THERE WAS NO RESISTANCE FELT DURING RETRACTION OF THE SDS AFTER IT FAILED TO CROSS THE LESION AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2072541

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CONCOMITANT MEDICAL DEVICES