BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3132549 · Received May 29, 2013

    Report

    Report Number
    2134265-2013-03484
    Event Type
    Death
    Date Received
    May 29, 2013
    Date of Event
    April 4, 2013
    Report Date
    May 2, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATION BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE STENT WAS DAMAGED AT THE PROXIMAL END. ONE STRUT ON THE SECOND MOST PROXIMAL ROW WAS LIFTED AND BENT DISTALLY. NO ISSUES WERE NOTED WITH THE TIP AND BALLOON OF THE DEVICE THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. BSC ID: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST CORONARY ANGIOPLASTY PROCEDURE, THE PATIENT EXPIRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 95% STENOSED, 18MM IN LENGTH TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED, 3.5MM IN DIAMETER RIGHT CORONARY ARTERY (RCA). THE TARGET LESION WAS PRE-DILATED. THE PHYSICIAN ATTEMPTED TO ADVANCE A 3.50X20MM PROMUS ELEMENT STENT TO THE LESION, BUT WAS UNABLE TO CROSS AND DEVICE WAS REMOVED FROM THE PATIENT. FOLLOWING REMOVAL OF THE DEVICE, THE PATIENT EXPERIENCED ACUTE VESSEL OCCLUSION, ATRIOVENTRICULAR BLOCK AND A MYOCARDIAL INFARCTION (MI). IT WAS NOTED THAT THERE WAS LOSS OF ACCESS AND THE PHYSICIAN COULD NOT GET BACK INTO THE OCCLUSION. THE PATIENT WAS TREATED WITH MEDICATION. IT WAS NOTED THAT THE PATIENT WAS IN SERIOUS CONDITION AND WAS HOSPITALIZED. ELEVEN DAYS POST PROCEDURE THE PATIENT EXPIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST CORONARY ANGIOPLASTY PROCEDURE, THE PATIENT EXPIRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 95% STENOSED, 18MM IN LENGTH TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED, 3.5MM IN DIAMETER RIGHT CORONARY ARTERY (RCA). THE TARGET LESION WAS PRE-DILATED. THE PHYSICIAN ATTEMPTED TO ADVANCE A 3.50X20MM PROMUS ELEMENT STENT TO THE LESION, BUT WAS UNABLE TO CROSS AND DEVICE WAS REMOVED FROM THE PATIENT. FOLLOWING REMOVAL OF THE DEVICE, THE PATIENT EXPERIENCED ACUTE VESSEL OCCLUSION, ATRIOVENTRICULAR BLOCK AND A MYOCARDIAL INFARCTION (MI). IT WAS NOTED THAT THERE WAS LOSS OF ACCESS AND THE PHYSICIAN COULD NOT GET BACK INTO THE OCCLUSION. THE PATIENT WAS TREATED WITH MEDICATION. IT WAS NOTED THAT THE PATIENT WAS IN SERIOUS CONDITION AND WAS HOSPITALIZED. ELEVEN DAYS POST PROCEDURE THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236330 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320350 15219200

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death