BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3002735 · Received March 13, 2013

    Report

    Report Number
    2024168-2013-01454
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 20, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE SHAFT SEPARATION WAS ABLE TO BE CONFIRMED. THE DEFLATION ISSUES AND DIFFICULTY REMOVING THE DEVICE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT DUE TO THE CONDITION OF THE RETURNED DEVICE. BASED ON A VISUAL INSPECTION 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. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. IT SHOULD BE NOTED THAT THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE STATES: DEFLATE THE BALLOON BY PULLING NEGATIVE ON THE INFLATION DEVICE. LARGER AND LONGER BALLOONS WILL TAKE MORE TIME TO DEFLATE THAN SMALLER AND SHORTER BALLOONS. CONFIRM BALLOON DEFLATION UNDER FLUOROSCOPY AND WAIT 10 - 15 SECONDS LONGER. APPLYING EXCESSIVE FORCE TO THE DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OF OR DAMAGE TO THE STENT AND / OR DELIVERY SYSTEM COMPONENTS.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4) FAILURE TO FOLLOW STEPS/INSTRUCTIONS. THE DEVICE HAS BEEN 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 THERE WERE TWO TARGET LESIONS LOCATED IN THE PROXIMAL TO MID RIGHT CORONARY ARTERY (RCA). THE 3.5 X 33 MM XIENCE XPEDITION STENT WAS ADVANCED AND DEPLOYED AT THE LESION WITHOUT ISSUE. REPORTEDLY, ONLY 5 TO 10 SECONDS WERE ALLOWED FOR DEFLATION OF THE STENT DELIVERY SYSTEM (SDS) BALLOON, THEN THE DEVICE WAS RETRACTED. THE SDS BALLOON WAS VISUALIZED UNDER FLUOROSCOPY TO ONLY BE PARTIALLY DEFLATED; HOWEVER, DESPITE OBSERVING THIS, THE DEVICE WAS STILL RETRACTED, AS THE PHYSICIAN STATED THAT HE WAS "IN A HURRY". RESISTANCE WAS ALSO ENCOUNTERED WITH THE 6 FRENCH NON-ABBOTT GUIDING CATHETER DURING RETRACTION, AS THE SDS WAS RETRACTED WITH THE BALLOON PARTIALLY INFLATED. THE DISTAL SHAFT SUBSEQUENTLY SEPARATED. NO INTERVENTION WAS PERFORMED, AS THE DEVICE WAS RETRACTED AS A UNIT WITH THE GUIDING CATHETER. THE XIENCE XPEDITION STENT WAS CONFIRMED TO BE ADEQUATELY APPOSED TO THE VESSEL WALL. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OF PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105237 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3012442

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE CATH: CORDIS JR4 6 FRENCH