BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2154536 · Received July 8, 2011

    Report

    Report Number
    2024168-2011-04885
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    March 1, 2011
    Report Date
    June 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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. AT THIS POINT A WIRE DISSECTION WAS NOTED IN THE RIGHT POSTERIOR LATERAL AND THE PROCEDURE WAS TERMINATED. THE SUBJECT WAS DISCHARGED ON (B)(6) 2011 AND THE EVENTS AS REPORTED WERE RESOLVED WITH NO RESIDUAL EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED. THE 2.5 X 12 MM PROMUS, THE 3.0 X 28 MM PROMUS, THE 3.5 X 28 MM PROMUS AND THE 3.5 X 12 PROMUS INDICATED IN B5 ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS. CONCOMITANT MEDICAL PRODUCTS: DIL CATH: SCIMED APEX, SCIMED NC QUANTUM APEX; GUIDE WIRE: SCIMED CHOICE EX SUPPORT, CHOICE FLOPPY; INFLATION: ENCORE 26; GUIDE CATH: 6 FR LAUNCHER, SHERPA; RHV: COPILOT; OTHER: PRONTO LP. (B)(4): INDICATION FOR USE/RE-INSERTION 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. PHYSICAL RESISTANCE WHEN CROSSING A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. THE PATIENT ANATOMY WAS MODERATELY TORTUOUS, WHICH LIKELY CONTRIBUTED TO THE PHYSICAL RESISTANCE. THE LESION HAD 80% RE-STENOSIS OF A PREVIOUSLY IMPLANTED STENT WITH APPEARS TO HAVE CONTRIBUTED TO THE REPORTED PHYSICAL RESISTANCE. ADDITIONAL PRE-DILATATION WAS PERFORMED AND THE 3.0 X 15 MM PROMUS WAS RE-INSERTED TO SUCCESSFULLY DEPLOY THE STENT. IT SHOULD BE NOTED THAT THE PROMUS INSTRUCTIONS FOR USE (IFU) STATES THAT AN UNEXPANDED STENT MAY BE RETRACTED INTO THE GUIDING CATHETER ONE TIME ONLY. AN UNEXPANDED STENT SHOULD NOT BE REINTRODUCED INTO THE ARTERY ONCE IT HAS BEEN PULLED BACK INTO THE GUIDING CATHETER. SUBSEQUENT MOVEMENT IN AND OUT THROUGH THE DISTAL END OF THE GUIDING CATHETER SHOULD NOT BE PERFORMED AS THE STENT MAY BE DAMAGED WHEN RETRACTING THE UNDEPLOYED STENT BACK INTO THE GUIDING CATHETER. ADDITIONALLY, IT WAS REPORTED THAT THE PROMUS STENT WAS IMPLANTED FOR TREATMENT OF AN 80% RE-STENOSED PROMUS STENT. IT SHOULD BE NOTED THAT THE PROMUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM (PROMUS STENT) IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH LESS THAN OR EQUAL TO 28 MM) WITH REFERENCE VESSEL DIAMETERS OF 2.5 MM TO 4.25 MM. IN THIS CASE, THE RE-INSERTION OR THE IMPLANTATION OF THE STENT TO TREAT IN-STENT RESTENOSIS DOES NOT APPEAR TO HAVE DIRECTLY CAUSED OR CONTRIBUTED TO THE REPORTED PHYSICAL RESISTANCE OR PATIENT EFFECTS. THE REPORTED ANGINA, EMBOLISM, ARRHYTHMIA (INCLUDING BRADYCARDIA), HYPOTENSION AND OCCLUSION ARE LISTED IN THE PROMUS IFU AS KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING. IN THIS CASE, THE REPORTED PHYSICAL RESISTANCE APPEARS TO BE RELATED TO OPERATIONAL CONTEXT AND ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. ADDITIONALLY, THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THE LOT HISTORY RECORD FOR THIS PRODUCT WAS NOT REVIEWED AND A SIMILAR INCIDENT QUERY WAS NOT PERFORMED BECAUSE THE LOT NUMBER WAS NOT REPORTED AND THE PRODUCT WAS NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUBJECT WAS RANDOMIZED INTO THE (B)(4) STUDY ON (B)(6) 2009. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH A 90% STENOSIS. THE TARGET LESION WAS TREATED WITH PRE-DILATATION, AND PLACEMENT OF A 2.5 X 12 MM STUDY STENT, AND POST-DILATATION WITH 19% RESIDUAL STENOSIS. THE SUBJECT WAS DISCHARGED ON (B)(6) 2009 ON ASPIRIN AND CLOPIDOGREL. THE SITE REPORTED AN EVENT OF CARDIAC CHEST PAIN WITH AN ONSET OF (B)(6) 2011. THE SUBJECT WAS HOSPITALIZED ON (B)(6) 2011, 567 DAYS POST INDEX PROCEDURE, AND TREATED WITH REVASCULARIZATION TO THE TARGET VESSEL/TARGET LESION FOR THE TREATMENT OF AN 80% RESTENOSIS OF THE PROMUS STENT WITH A DRUG ELUTING STENT. TREATMENT WAS ALSO PERFORMED ON THE RIGHT CORONARY ARTERY (RCA) A NON TARGET VESSEL, FOR THE TREATMENT OF RESTENOSIS OF PREVIOUSLY PLACED NON-ABBOTT STENTS WITH THE PLACEMENT OF FOUR PROMUS STENTS. THE ATTEMPT TO CROSS WITH THE 3.0 X 15 PROMUS STENT FAILED INITIALLY; HOWEVER, AFTER ADDITIONAL PREDILATATION, WAS ABLE TO CROSS AND BE DEPLOYED. A 3.0 X 28 MM, 3.5 X 28 MM AND 3.5 X 12 MM STENTS WERE DEPLOYED OVERLAPPING THE IN THE RCA. DURING THE TREATMENT OF THE RCA, THE PATIENT WAS EXPERIENCING CHEST PAIN AND ST ELEVATION IN THE INFERIOR LEADS. THE PATIENT WAS TREATED FOR BRADYCARDIA WITH A PACEMAKER. AN INTRA AORTA BALLOON PUMP WAS PLACED AS THE PATIENT WAS MANIFESTING EVIDENCE OF HYPOTENSION. THERE WAS A NO REFLOW DUE TO EXTENSIVE ATHERO-EMBOLIZATION FROM THE STENTING OF THE MID RCA. INTEGRELIN AND ADENOSINE WERE ADMINISTERED AND FLOW DID NOT IMPROVE.

    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 68 YR Hospitalization| R