BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1984130 · Received February 10, 2011

    Report

    Report Number
    2024168-2011-00795
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 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
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION; HOWEVER, IT WAS NOT POSSIBLE TO PERFORM A THOROUGH ANALYSIS ON THE PRODUCT BECAUSE IT WAS NOT RETURNED FOR INVESTIGATION. A CINE OF THE PROCEDURE WAS RECEIVED AND REVIEWED BY AN ABBOTT CLINICAL SPECIALIST. THE REVIEWER NOTED THAT ANGIOGRAMS REVEAL A TIGHT, DISCRETE LESION IN THE PROXIMAL LEFT CIRCUMFLEX (LCX). A GUIDE WIRE IS POSITIONED IN THE LCX/OBTUSE MARGINAL (OM) AND 3 BALLOON DILATATIONS ARE VIEWED IN THE NEXT 3 RUNS. APPARENTLY, ONE OF THE DILATATIONS WAS OF STENT DEPLOYMENT AS A STENT SHADOW IS VISIBLE ON THE NEXT CONTRAST INJECTION. THE STENT APPEARS UNDER-EXPANDED. THERE ARE SIX RUNS SHOWING POST-DILATATIONS. THE NEXT RUN AFTER THE POST-DILATATIONS SHOWS A SHORTENED STENT WITH A SHORT RADIOPACITY WITHIN THE STENT SHADOW. THERE IS NO ARTIFACT OR RADIOPACITIES VISUALIZED IN THE VESSELS DISTAL TO THE STENT. THE REVIEWER CONCLUDED THAT THERE ARE NO IMAGES OF THE WIRE BEING RETRACTED FROM THE VESSEL OR ENTRAPPED IN THE STENT TO CONFIRM BY CINE THE DIFFICULTY IN WIRE RETRACTION; HOWEVER, THE SHORTENED STENT LENGTH SUGGESTS THAT SOME ITEM CAUGHT ON THE STENT CAUSING IT TO ACCORDION. THE RADIOPACITY SEEN IN THE SHORTENED STENT IS MOST LIKELY A FRAGMENT OF THE GUIDE WIRE TIP. THERE IS NO SUGGESTION OF A STENT FRAGMENT EMBOLIZATION OR A REASON FOR THE GUIDE WIRE ENTANGLEMENT OR ENTRAPMENT WITH THE STENT. IN THIS CASE, IT WAS REPORTED THE PROMUS STENT WAS SUCCESSFULLY IMPLANTED; HOWEVER DURING REMOVAL OF THE GUIDE WIRE, THE STENT WAS DAMAGED AND SEPARATED. FACTORS THAT COULD CONTRIBUTE TO THE REPORTED DIFFICULTIES INCLUDE, BUT ARE NOT LIMITED TO, INTERACTION OF THE GUIDE WIRE WITH THE STENT IMPLANT IF THE STENT IS NOT FULLY EXPANDED AND APPOSED, THE GUIDE WIRE CAUGHT UNDERNEATH THE IMPLANTED STENT, OR DAMAGE TO THE STENT. TO ENSURE THIS TYPE OF OCCURRENCE IS NOT RELATED TO A POTENTIAL MANUFACTURING OR PRODUCT DEFICIENCY, A SAMPLING OF UNITS ARE DESTRUCTIVELY TESTED TO VERIFY PROPER STENT DEPLOYMENT. IN THIS CASE, THE STENT DELIVERY SYSTEM (SDS) AND GUIDE WIRE 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 DIFFICULTIES EXPERIENCED. IT WAS NOTED DURING REVIEW OF THE CINE THAT THE STENT MAY NOT HAVE SEPARATED BUT WAS JUST DAMAGED AND ACCORDIONED RESULTING IN THE STENT LOOKING SHORTER ON ANGIOGRAM. THE CINE ALSO NOTED THAT IT IS POSSIBLY THE GUIDE WIRE SEPARATED IN THE LESION, RESULTING IN WHAT COULD HAVE BEEN PERCEIVED BY THE PHYSICIAN AS A SEPARATED PORTION OF THE STENT. THE EMBOLIZED MATERIAL REMAINS IN THE PATIENT ANATOMY. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. IN THIS CASE, A CONCLUSIVE CAUSE FOR WHY THE STENT WAS EXPLANTED BY THE GUIDE WIRE OR STENT SEPARATION COULD NOT BE DETERMINED; HOWEVER, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. 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 THE 99% STENOSED LESION WAS WIRED WITH A NON-ABBOTT DEVICE. PREDILATATION WAS PERFORMED WITH A 3.5 X 15 NON-ABBOTT BALLOON CATHETER AND THEN FOLLOWED UP WITH THE PROMUS STENT. FOLLOWING THE STENT DEPLOYMENT, A 3.5 X 8 NON-ABBOTT BALLOON CATHETER WAS INTRODUCED AND IT IS UNKNOWN WHAT ATMOSPHERES WERE APPLIED. THE NON-ABBOTT BALLOON CATHETER WAS WITHDRAWN AND A PICTURE WAS TAKEN OF THE VESSEL AND THEN, AS THE WIRE WAS BEING PULLED OUT, THE WIRE GOT STUCK ON THE STENT. THE WIRE WAS PULLED ON AND IT FINALLY CAME OUT. A FINAL PICTURE WAS TAKEN AND IT APPEARED AS THOUGH ONLY 12 MM OF THE STENT REMAINED IN THE LESION AREA. DISTAL TO THE STENT, THERE WAS A HAZY, RADIOPAQUE "SOMETHING" THAT WAS DOWN DISTAL OF THE LESION; THIS MAY HAVE BEEN THE OTHER 6 MM PORTION OF THE PROMUS STENT. THE EMBOLIZED PORTION OF THE STENT COULD NOT BE RETRIEVED, AS MULTIPLE ATTEMPTS TO REGAIN ACCESS INTO THE DISTAL VESSEL WERE UNSUCCESSFUL, SO IT WAS LEFT AS IS. THE EMBOLIZED PIECE OF THE STENT WAS IN THE DISTAL CIRCUMFLEX. NO ADDITIONAL EVENT OR PATIENT INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 99% STENOSED LESION WAS WIRED WITH A NON-ABBOTT DEVICE. PREDILATATION WAS PERFORMED WITH A 3.5 X 15 NON-ABBOTT BALLOON CATHETER AND THEN FOLLOWED UP WITH THE PROMUS STENT. FOLLOWING THE STENT DEPLOYMENT, A 3.5 X 8 NON-ABBOTT BALLOON CATHETER WAS INTRODUCED AND IT IS UNKNOWN WHAT ATMOSPHERES WERE APPLIED. THE NON-ABBOTT BALLOON CATHETER WAS WITHDRAWN AND A PICTURE WAS TAKEN OF THE VESSEL AND THEN, AS THE WIRE WAS BEING PULLED OUT, THE WIRE GOT STUCK ON THE STENT. THE WIRE WAS PULLED ON AND IT FINALLY CAME OUT. A FINAL PICTURE WAS TAKEN AND IT APPEARED AS THOUGH ONLY 12 MM OF THE STENT REMAINED IN THE LESION AREA. DISTAL TO THE STENT, THERE WAS A HAZY, RADIOPAQUE "SOMETHING" THAT WAS DOWN DISTAL OF THE LESION; THIS MAY HAVE BEEN THE OTHER 6 MM PORTION OF THE PROMUS STENT. THE EMBOLIZED PORTION OF THE STENT COULD NOT BE RETRIEVED, SO IT WAS LEFT AS IS. THE EMBOLIZED PIECE OF THE STENT WAS IN THE DISTAL CIRCUMFLEX. THOUGH REQUESTED, NO ADDITIONAL EVENT OR PATIENT INFORMATION WAS PROVIDED.

    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 0083141

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other| R GUIDE WIRE: ATW WIRE (CORDIS)