BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2874223 · Received December 14, 2012

    Report

    Report Number
    2024168-2012-07960
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 21, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    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. THE STENT REMAINS IN THE PATIENT. 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.ALTHOUGH A CONCLUSIVE CAUSE FOR THE PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE IF ANY CANNOT BE DETERMINED, THROMBOSIS AND ANGINA ARE LISTED IN THE (B)(4) XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENT OF CORONARY STENTING PROCEDURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2012, THE PATIENT HAD A 2.5 X 23 MM XIENCE PRIME STENT IMPLANTED IN THE PROXIMAL LEFT CIRCUMFLEX (LCX) WITH THREE INFLATIONS UP TO 9 ATMOSPHERES (ATM). POST-DILATATION WAS PERFORMED USING THE STENT DELIVERY SYSTEM (SDS) BALLOON FOR TWO INFLATIONS AT 9 ATM FOR 30 SECONDS EACH. AS THE STENT SEEMED TO BE WELL APPOSED TO THE VESSEL WALL ON ANGIOGRAPHY, THE PROCEDURE WAS COMPLETED AND POST-PROCEDUAL INTRA-VASCULAR ULTRA SOUND (IVUS) EXAMINATION WAS NOT PERFORMED. ON (B)(6) 2012, THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL, DUE TO CHEST PAIN. THROMBUS ASPIRATION WAS PERFORMED WITH A NON-ABBOTT ASPIRATION CATHETER. AND DILATATION WAS PERFORMED WITH TWO NON-ABBOTT BALLOON CATHETERS. IVUS EXAMINATION WAS THEN PERFORMED AND CONFIRMED THAT THE PROXIMAL PART OF THE XIENCE PRIME STENT WAS HAD NOT BEEN COMPLETELY APPOSED TO THE VESSEL WALL. THE XIENCE PRIME STENT WAS DILATED WITH A 2.75 X 15 MM NON-ABBOTT BALLOON CATHETER AT 20 ATM AND THE PROCEDURE WAS COMPLETED. THE PHYSICIAN COMMENTED THAT THE THROMBOSIS FORMATION WAS NOT DUE TO ANY ISSUE WITH THE DEVICE, BUT THAT IT WAS CAUSED BY THE STENT IMPLANT NOT BEING PROPERLY APPOSED TO THE VESSEL WALL. NO ADVERSE PATIENT SEQUELA WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 2072341

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R