BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2003222 · Received February 28, 2011

    Report

    Report Number
    2024168-2011-01249
    Event Type
    Injury
    Date Received
    February 28, 2011
    Date of Event
    January 20, 2011
    Report Date
    February 3, 2011
    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). EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD IN THE GUIDE WIRE LUMEN AND ON THE ENTIRE LENGTH OF THE STENT DELIVERY SYSTEM (SDS), SUGGESTING THAT THE DEVICE WAS ADVANCED OVER A GUIDE WIRE AND INTO THE PATIENT. THE TIP LENGTH WAS MEASURED AND MET MANUFACTURING CRITERIA. THERE WERE TWO BENDS IN THE HYPOTUBE THAT WERE NOT OBSERVED DURING PRODUCT INSPECTION PRIOR TO USE AND THUS, MAY HAVE OCCURRED DURING OR AFTER THE PROCEDURAL ATTEMPTS TO CROSS THE LESION OR POSSIBLY AS A RESULT OF PACKAGING AND SHIPMENT BACK TO ABBOTT VASCULAR FOR ANALYSIS. IT WAS CONFIRMED THAT THE STENT IMPLANT WAS DISLODGED FROM THE BALLOON AND WAS NOT RETURNED. HOWEVER, CRIMP MARKS WERE VISIBLE ON THE TIGHTLY FOLDED BALLOON AND BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT ARE NOT LIMITED TO: PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, ACCESSORY DEVICE SUPPORT, AND/OR INTERACTION WITH PREVIOUSLY IMPLANTED STENTS. IT IS LIKELY THAT INTERACTION WITH THE MODERATELY TORTUOUS/MILDLY CALCIFIED LESION CONTRIBUTED TO THE FAILURE TO CROSS AND CAUSED THE STENT IMPLANT TO BECOME DISRUPTED ON THE BALLOON. THEN, AS THE SDS WAS BEING REMOVED, RESISTANCE WAS FELT AND THE STENT DISLODGED AS IT INTERACTED WITH THE TIP OF THE GUIDING CATHETER. A BALLOON CATHETER WAS INFLATED TO WITHDRAW THE LOOSE STENT (ADDITIONAL THERAPY/NON-SURGICAL TREATMENT). SINCE THERE WAS NO REPORT OF ANY DAMAGE TO THE SDS OR STENT IMPLANT PRIOR TO USE, THIS SUGGESTS A PRODUCT QUALITY DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. TO ENSURE THE REPORTED DIFFICULTIES ARE NOT THE RESULT OF A MANUFACTURING DEFICIENCY, ALL SDS ARE INSPECTED FOR PROPER STENT PLACEMENT, STENT DAMAGE AND CRIMPED STENT OUTER DIAMETER. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED PRIOR TO RELEASE TO VERIFY STENT DISLODGEMENT FORCE. A CINE WAS PROVIDED AND REVIEWED BY A CLINICAL SPECIALIST. THERE IS RESTENOSIS OF STENTS IN THE MID LEFT CIRCUMFLEX (LCX) AND THE PROXIMAL OBTUSE MARGINAL (OM) AT THE POINT OF BIFURCATION. BOTH RESTENOSED AREAS ARE BALLOON DILATED. A STENT IS THEN DEPLOYED DISTAL TO THE STENT IN THE OM, WITH SOME OVERLAP. ADDITIONAL BALLOON DILATATIONS ARE PERFORMED IN THE LCX FOLLOWED BY LCX/OM KISSING INFLATIONS. ANOTHER STENT IS DEPLOYED IN THE PROXIMAL LCX. HOWEVER, IT WAS CONCLUDED THAT THERE ARE NO IMAGES SHOWING A STENT SYSTEM NOT POSITIONED WHERE DEPLOYED. NOR ARE THERE IMAGES OF A DISLODGED STENT. THUS, THE INCIDENT DESCRIPTION CANNOT BE CONFIRMED BY CINE. THE FAILURE TO CROSS, DIFFICULTY TO REMOVE, STENT DISLODGMENT AND SUBSEQUENT BENDS APPEAR TO BE RELATED TO OPERATIONAL CONTEXT. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. ADDITIONALLY, ALL STENT DELIVERY SYSTEMS ARE 100% INSPECTED FOR PROPER STENT PLACEMENT, STENT DAMAGE AND CRIMPED STENT OUTER DIAMETER. A SAMPLING OF UNITS IS ALSO DESTRUCTIVELY TESTED PRIOR TO RELEASE TO VERIFY STENT DISLODGEMENT FORCE.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. GUIDE WIRE: BMW. GUIDE CATH: LAUNCHER 6F EBU 4. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. 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 PRE-DILATATION WAS PERFORMED PRIOR TO A NO-CROSS OF THE PROMUS WITH A RESTENOSED STENT, WHICH REQUIRED REMOVAL OF THE PROMUS RX STENT DELIVERY SYSTEM (SDS). DURING REMOVAL, THE PHYSICIAN EXPERIENCED RESISTANCE AND STENT DISLODGEMENT AT THE BIFURCATION OF THE RAMUS AND LEFT ANTERIOR DESCENDING ARTERIES. THE LOST STENT WAS THEREFORE CAUGHT WITH A BALLOON CATHETER THAT WAS INFLATED TO WITHDRAW THE LOOSE STENT. ANOTHER PROMUS RX SDS WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT EFFECTS. NO ADDITIONAL 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 9051441

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention