BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2955042 · Received February 11, 2013

    Report

    Report Number
    2024168-2013-00764
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 17, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. DIFFICULTY/RESISTANCE REMOVING THE DEVICE POST-DEPLOYMENT COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. SHAFT SEPARATION WAS CONFIRMED. BASED ON VISUAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. 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. IT SHOULD BE NOTED THAT THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE STATES: SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING EITHER LESION ACCESS OR REMOVAL OF THE DELIVERY SYSTEM POST-STENT IMPLANTATION, THE ENTIRE SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT. FAILURE TO FOLLOW THESE STEPS AND/OR APPLYING EXCESSIVE FORCE TO THE DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND/OR DELIVERY SYSTEM COMPONENTS. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4). THE DEVICE WAS RECEIVED. 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 DURING A PROCEDURE TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY WITH HEAVY CALCIFICATION AND 80% STENOSIS, PRE-DILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON; MULTIPLE INFLATIONS UP TO 16 ATMOSPHERES. A 3.5X23 RX XIENCE PRIME STENT DELIVERY SYSTEM (SDS) WAS ADVANCED WITHOUT RESISTANCE AND SUCCESSFULLY DEPLOYED. THE SDS BALLOON WAS DEFLATED AND DURING WITHDRAWAL SOME RESISTANCE WAS FELT INSIDE OF THE IMPLANTED STENT AS THE DEFLATED BALLOON WAS SLIGHTLY STUCK ON THE DEPLOYED STENT IMPLANT. THE PHYSICIAN CONTINUED TO PULL BACK AND THE DISTAL SHAFT SEPARATED FROM THE HYPOTUBE IN THE PATIENT ANATOMY. REPORTEDLY, THE SEPARATED DISTAL PORTION WAS RETRIEVED FROM THE AORTA WITH A SNARE DEVICE AND NOTHING REMAINED IN THE PATIENT ANATOMY. THE PATIENT OUTCOME WAS SATISFACTORY. THERE WAS NO ADVERSE PATIENT SEQUELAE AND THE PROCEDURE WAS PROLONGED 10-15 MINUTES DUE TO THE SNARING BUT THE DELAY WAS NOT CLINICALLY SIGNIFICANT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58331 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2083041

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention