BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2370689 · Received December 13, 2011

    Report

    Report Number
    2024168-2011-08398
    Event Type
    Injury
    Date Received
    December 13, 2011
    Date of Event
    November 17, 2011
    Report Date
    November 18, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    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. DURING THE PROCESS/ATTEMPTS TO REMOVE THE STUCK IVUS CATHETER, IT WAS NOTED THAT THE 2.75 MM X 15 MM PROMUS STENT WAS DAMAGED. IT WAS FURTHER NOTED THAT THE 2.75 MM X 15 MM PROMUS STENT WAS CRUSHED TO THE VESSEL WALL DURING THE ATTEMPTS TO REMOVE THE STUCK IVUS CATHETER WHEN USING TWO MICRO CATHETERS. DESPITE ALL ATTEMPTS, THE IVUS CATHETER COULD NOT BE FREED AND REMOVED. A SURGICAL PROCEDURE WAS PERFORMED THE FOLLOWING DAY; THE OUTCOME HAS BEEN REQUESTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. SHEATH: INTRODUCER SHEATH 6FR 25CM, OTHER: ATLANTIS SR PRO2(IVUS). FACTORS THAT COULD CONTRIBUTE TO THE REPORTED DIFFICULTY INCLUDE, BUT ARE NOT LIMITED TO, INTERACTION OF THE IVUS WITH THE STENT IMPLANT IF THE STENT IS NOT FULLY EXPANDED AND APPOSED, DAMAGE TO THE STENT OR IVUS. IN THIS CASE, THE PROMUS STENT DELIVERY SYSTEM (SDS) AND IVUS CATHETER USED WERE NOT RETURNED FOR ANALYSIS WHICH MAY HAVE AIDED THE INVESTIGATION. THERE WAS NO NOTE OF ANY DAMAGE TO THE STENT IMPLANT OBSERVED PRIOR TO THE PROCEDURE, WHICH MAY SUGGEST THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE DIFFICULTY EXPERIENCED. IT IS POSSIBLE THAT DURING THE MANIPULATION ATTEMPTS OF THE IVUS CATHETER INSIDE THE DEPLOYED STENT, THE IVUS MAY HAVE INTERACTED WITH THE STENT, CAUSING DAMAGE TO THE STENT STRUTS. THE LOT HISTORY RECORD FOR THIS PRODUCT WAS NOT REVIEWED AND A SIMILAR INCIDENT QUERY WAS NOT PERFORMED BECAUSE THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN. ALL STENT DELIVERY SYSTEMS ARE SUBJECTED TO A VISUAL INSPECTION. IN ADDITION, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY PROPER STENT DEPLOYMENT. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF A HIGH LATERAL, MODERATELY TORTUOUS, LEFT ANTERIOR DESCENDING ARTERY LESION, THREE PROMUS WERE IMPLANTED A 2.5 MM X 28 MM DISTAL, 2.5 MM X 28 MM, AND 2.75 MM X 15 MM PROXIMAL. INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS PERFORMED WITHOUT ISSUE. IT WAS CONFIRMED WITH ANGIOGRAPHY AND IVUS THAT THERE WAS NO ISSUES WITH THE IMPLANTATION OF THE PROMUS STENTS AND APPOSITION TO THE VESSEL WALL. DURING THE ATTEMPT TO REMOVE THE IVUS CATHETER RESISTANCE WAS MET AT THE STENT OVERLAP BETWEEN THE FIRST AND SECOND 2.5 MM X 28 MM PROMUS STENTS; THE IVUS CATHETER WAS STUCK AND COULD NOT BE REMOVED. THE GUIDE WIRE WAS REMOVED. EVASIVE MEASURES WERE INITIATED BY DISMANTLING THE IVUS DEVICE. THE IMAGING CORE WAS REMOVED; A NON-ABBOTT GUIDE WIRE WAS INSERTED, HOWEVER THE IVUS CATHETER REMAINED STUCK. AN ASAHI MIRACLE 6, A 0.018 AND 0.25 ANGIOGRAPHY GUIDE WIRE, AND A NON-ABBOTT GUIDE WIRE WERE USED, BUT WERE UNSUCCESSFUL IN FREEING THE IVUS CATHETER. THE OUTER SHAFT OF THE IVUS CATHETER WAS CUT AND A 4.3 FR NON-ABBOTT GUIDING CATHETER WAS INSERTED BUT UNSUCCESSFUL IN RELEASING THE IVUS CATHETER. A NON-ABBOTT ASPIRATION CATHETER WAS INSERTED OVER THE OUTER SHAFT OF THE IVUS CATHETER BUT WAS UNSUCCESSFUL IN FREEING THE DEVICE. A DIFFERENT APPROACH WAS ATTEMPTED FROM THE RIGHT RADIAL USING A 6 FR 3.5 GUIDING CATHETER, A WHISPER AND ASAHI FIELDER FINE CROSS WERE ADVANCED BUT COULD NOT BE DELIVERED TO THE STUCK PART. AN ASAHI MIRACLE 12 WAS INSERTED TO THE LUMEN WHERE THE IMAGING CORE WAS INSERTED BUT COULD NOT CROSS THROUGH THE LUMEN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization| R