BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3140993 · Received June 3, 2013

    Report

    Report Number
    2024168-2013-03442
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 18, 2013
    Report Date
    May 18, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECT OF DISSECTION, AS LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE, IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING PROCEDURES. 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.

    Additional Manufacturer Narrative · 1

    (B)(4).EVALUATION SUMMARY:THE DEVICE WAS RETURNED FOR EVALUATION; HOWEVER, THIS INCIDENT CONTAINED PATIENT EFFECTS WITH NO ALLEGATION OF A DEVICE ISSUE AND, AS SUCH, IS NOT ON ITS OWN AN INDICATION OF A PRODUCT DEFICIENCY. ADDITIONALLY, VISUAL ANALYSIS WAS PERFORMED FOR THE RETURNED DEVICE AND 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 INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE PROXIMAL CIRCUMFLEX ARTERY WITH MODERATE TORTUOSITY AND HEAVY CALCIFICATION. PRE-DILATATION WAS PERFORMED WITH A 1.5 X 8 MM MINI TREK AT 12 ATMOSPHERES (ATM), AND A 2.5 X 8 MM MINI TREK AT 12 ATM; HOWEVER, DUE TO THE ANATOMY, THE LESION WAS NOT OPENED WELL ENOUGH TO ADVANCE THE STENT. ADDITIONAL DILATATION WAS PERFORMED WITH A 2.5 X 8 MM NC TREK BALLOON TO OPEN THE CALCIFIED SEGMENT. TIMI II FLOW WAS OBSERVED, AND THE 3.0 X 33 MM XIENCE PRIME STENT WAS DEPLOYED AT 12 ATMOSPHERES. WHILE DEFLATING THE BALLOON OF THE STENT DELIVERY SYSTEM, A DISTAL EDGE DISSECTION WAS OBSERVED. A XIENCE PRIME STENT WAS USED TO TREAT THE DISSECTION. THE PATIENT HAD A GOOD RESULT, WITH TIMI III FLOW. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244437 XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2082741

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention