BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PROA EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 19982394 · Received August 14, 2024

    Report

    Report Number
    2024168-2024-09575
    Event Type
    Malfunction
    Date Received
    August 14, 2024
    Date of Event
    July 23, 2024
    Report Date
    November 20, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    UDI-DI
    08717648226571
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED MATERIAL RUPTURE AND ACTIVATION FAILURE WERE CONFIRMED. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE WERE NO OTHER COMPLAINT FROM THIS LOT. THE DEVICE WAS SENT FOR SCANNING ELECTRON MICROSCOPE (SEM) ANALYSIS DUE TO THE REPORTED RUPTURE, THE SEM ANALYSIS STATED, THE BALLOON FAILURE MAY BE ATTRIBUTED TO MECHANICAL DAMAGE TO THE OUTER SURFACE. THE STENT WAS DAMAGED DURING REMOVAL FROM THE BALLOON AND WAS NOT AVAILABLE FOR ADDITIONAL IMAGING. AN EXACT FAILURE ORIGIN LOCATION WAS NOT DETERMINED. DAMAGE TO THE OUTER SURFACE AND AT THE SEPARATED EDGE WAS OBSERVED. A PRINCIPAL ENGINEER FROM THE BUSINESS UNIT ANALYZED THE SEM REPORT AND REPORTED THE FOLLOWING: THE REPORTED DIFFICULTY DOES NOT APPEAR TO BE RELATED TO MANUFACTURING AS THE UNIT WAS REPORTEDLY PASSED THROUGH A MODERATELY CALCIFIED AND 92% STENOSED LESION. THE DISTAL BALLOON MATERIAL HAD DAMAGE BY THE EDGES CONSISTENT WITH INTERACTION WITH DIFFICULT ANATOMY. THE DEVICE WAS ABLE TO REPORTEDLY REACH 16 ATMOSPHERES, HOWEVER, DUE TO THE OBSERVED BALLOON DAMAGE THE BALLOON BURST CAUSING THE NATURE OF THE RUPTURE OBSERVED DURING RETURN ANALYSIS OF THE DEVICE. THE NATURE OF THE RUPTURE IN COMBINATION WITH THE OBSERVED DAMAGE TO THE DISTAL BALLOON MATERIAL WOULD MEAN IT WAS NOT MANUFACTURING RELATED. BASED ON THE INFORMATION PROVIDED AND ANALYSIS OF THE RETURNED DEVICE, THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE. BASED ON THE RESULTS OF THE COMPLAINT INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. THE XIENCE PROA DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE US; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIALLY FILED REPORTS IT WAS REPORTED THAT THE RUPTURE OCCURRED AT 16 ATMOSPHERES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY WITH CALCIFICATION AND 95% STENOSIS. DURING INFLATION OF THE 2.5X38 MM XIENCE PROA STENT DELIVERY SYSTEM, THE PRESSURE ON THE MANOMETER DROPPED AND CONTRAST WAS NOTED IN THE ARTERY; INDICATING THAT THE BALLOON HAD RUPTURED. ADDITIONALLY, THE STENT FAILED TO DEPLOY. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT SDS WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560837 XIENCE PROA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 1128250-38 4012541 08717648226571

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown