BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2912026 · Received January 11, 2013

    Report

    Report Number
    2024168-2013-00261
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 18, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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:BALANCE MIDDLEWEIGHT, GUIDE CATH: XC 3.5, OTHER: ABSORB BIORESORBABLE VASCULAR SCAFFOLD. THE CUSTOMER REPORTED THE STENT REMAINS IN THE PATIENT. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION AND THROMBOSIS ARE LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE IF ANY CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED AN ABSORB SCAFFOLD (PROXIMAL LAD) AND A XIENCE PRIME (DISTAL LAD) ON (B)(6) 2012, FOR TREATMENT OF A NON-ST ELEVATION MYOCARDIAL INFARCTION (STEMI). THE PATIENT'S COMPLIANCE WAS SOMEWHAT QUESTIONABLE; SHE WAS ON TREATMENT WITH ASPIRIN AND TICAGRELOR. THE PATIENT WAS ADMITTED ON (B)(6) 2012, WITH STEMI OF THE ANTERIOR WALL. ANGIOGRAPHY SHOWED A COMPLETE IN-ABSORB SCAFFOLD THROMBOTIC OCCLUSION. AFTER THE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY OPTICAL COHERENCE TOMOGRAPHY (OCT) WAS PERFORMED WHICH SHOWED THROMBUS IN BOTH THE ABSORB SCAFFOLD AND THE XIENCE PRIME. THERE WAS A RUPTURED PLAQUE IN THE VESSEL BETWEEN THE TWO STENTS. THE PHYSICIAN'S FIRST IMPRESSION IS THAT THIS IS NOT A CASE OF IN-SCAFFOLD THROMBOSIS, BUT RATHER A PLAQUE RUPTURE WITH A THROMBUS THAT EXTENDED PROXIMAL AND DISTAL TO THE SITE OF RUPTURE. THE THROMBOTIC OCCLUSION WAS TREATED WITH AN UNKNOWN BALLOON CATHETER AND TWO XIENCE V STENTS. THE PATIENT IS STABLE AND IN GOOD CONDITION. TIMI 3 GRADE FLOW WITH A GOOD RESULT VIA OCT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18475 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S