BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2981425 · Received February 27, 2013

    Report

    Report Number
    2024168-2013-01155
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 2013
    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 ANALYSIS OF THE RETURNED DEVICE CONFIRMED A LEAK IN THE BALLOON. A REVIEW OF THE LOT HISTORY RECORD FOR THE MANUFACTURING OF THE REPORTED LOT REVEALED NO ASSOCIATED NONCONFORMING MATERIAL RECORDS RELATED TO BALLOON RUPTURES/LEAKS, INDICATING ALL LOT RELEASE TESTING MET ACCEPTANCE SPECIFICATIONS. A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED NO OTHER SIMILAR INCIDENTS OF BALLOON LEAKS/RUPTURES. BASED ON A RELATED RECORDS REVIEW, THERE IS NO EVIDENCE THAT THIS PRODUCT DEFICIENCY AFFECTS INVENTORY OR DISTRIBUTED PRODUCT.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT MEDICAL DEVICES: GUIDE WIRE: SION BLACK; GUIDE CATH: RADIGUIDE 6F JL4. 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 THE PROCEDURE WAS TO TREAT A 75% STENOSED LESION IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY WITH MILD CALCIFICATION. INTRAVASCULAR ULTRASOUND (IVUS) WAS ADVANCED, BUT COULD NOT CROSS TO THE LESION. DILATATION WAS PERFORMED AND IVUS WAS ABLE TO BE PERFORMED. THE 2.75 X 28 XIENCE PRIME STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE DISTAL LESION AND INFLATED TO 10 ATMOSPHERES (ATM); HOWEVER, CONTRAST WAS OBSERVED LEAKING FROM THE DISTAL PORTION OF THE BALLOON AND IT WAS DETERMINED THAT A BALLOON RUPTURE OCCURRED. AN INDEFLATOR WAS USED TO HOLD THE PRESSURE FOR 30 SECONDS, AND THE STENT WAS IMPLANTED IN THE LESION SUCCESSFULLY. THE PROXIMAL LESION WAS TREATED WITH ANOTHER XIENCE PRIME STENT. DURING THE FINAL IVUS, A HEMATOMA WAS OBSERVED, WHICH APPEARED TO BE A DISTAL EDGE DISSECTION WITH THE 2.75 X 28 MM XIENCE PRIME STENT AND A SPASM WAS NOTED DISTAL TO THE STENT. NITROGLYCERIN WAS ADMINISTERED, BUT THE DISTAL NARROW PORTION OF THE VESSEL DID NOT IMPROVE; THEREFORE, AN ADDITIONAL 2.5 X 18 MM XIENCE PRIME STENT WAS IMPLANTED FOR TREATMENT AND THE PROCEDURE WAS COMPLETED. THE PATIENT HAD A GOOD OUTCOME. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85679 XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 111014Q

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention