BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRO EVEROLIMUS ELUTING RX CORONARY STENT SYSTEM

    MDR report key: 3658267 · Received March 4, 2014

    Report

    Report Number
    2024168-2014-01245
    Event Type
    Injury
    Date Received
    March 4, 2014
    Date of Event
    February 6, 2014
    Report Date
    February 7, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    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. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE XIENCE PRO IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE US. THE PMA# LISTED IS BASED ON THE PREDICATE DEVICE (XIENCE V) AND IS THEREFORE SIMILAR TO A DEVICE SOLD IN THE US.

    Additional Manufacturer Narrative · 1

    (B)(4)/ EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE BALLOON RUPTURE WAS ABLE TO BE CONFIRMED. THE DIFFICULT TO DEPLOY PARTIAL / MOVEMENT, AND DIFFICULT TO POSITION COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON A VISUAL AND FUNCTIONAL 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. A QUERY/REVIEW OF THE ELECTRONIC COMPLAINT DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY. PRE-DILATATION WAS PERFORMED AND THE 2.5 X 23 MM XIENCE PRO STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION WITHOUT ISSUE. DURING INFLATION OF THE SDS TO AN UNKNOWN PRESSURE, THE BALLOON RUPTURED. THE STENT WAS NOT FULLY DEPLOYED; THEREFORE, A BALLOON CATHETER WAS USED TO EXPAND THE STENT. DURING THE INFLATION TO OPEN THE STENT, THE STENT MOVED A LITTLE BIT IN THE LESION. THE NURSE COULD NOT SAY IF PROXIMALLY OR DISTALLY. THE STENT WAS FULLY DEPLOYED, BUT WSA PARTIALLY IN HEALTHY TISSUE. THE 2.5 X 28 MM XIENCE PRO SDS AND THE 2.5 X 18 MM XIENCE PRO SDS WERE BOTH ADVANCED, BUT COULD NOT CROSS TO THE LESION. IT IS UNKNOWN IF THE DEVICES DID NOT CROSS DUE TO THE ANATOMY OR DUE TO INTERACTION WITH THE PREVIOUSLY PLACED STENT. THERE WAS NO DAMAGE NOTED TO THE IMPLANTED STENT. THE PROCEDURE WAS STOPPED AND PART OF THE LESION REMAINS UNTREATED. THE NEXT DAY, THE PATIENT RETURNED TO THE CATH LAB FOR A FOLLOW-UP DIAGNOSTIC PROCEDURE, AND THE RESULT IN THE VESSEL LOOKS STILL GOOD. THE PATIENT IS FINE AND 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
    129829 XIENCE PRO EVEROLIMUS ELUTING RX CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3112541

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention