BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 7723275 · Received July 26, 2018

    Report

    Report Number
    2134265-2018-06962
    Event Type
    Injury
    Date Received
    July 26, 2018
    Report Date
    July 11, 2018
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DAOYUAN SI, MD, PHD, ET.AL, ¿TREATMENT OF LONGITUDINAL STENT COMPRESSION UNDER INTRAVENOUS ULTRASOUND GUIDANCE: A CASE REPORT¿, MEDICINE (2017) 96:51(E9405). DEVICE IS COMBINATION PRODUCT. (B)(4). IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE THAT LONGITUDINAL STENT COMPRESSION AND STENT MALAPPOSITION OCCURRED. THE PATIENT HAD A SEVEN YEAR HISTORY OF CHEST PAIN AND WAS HOSPITALIZED AFTER EXPERIENCING EXACERBATION OF PAIN FOR TWO MONTHS. ELECTROCARDIOGRAPHY SHOWED NO SIGNIFICANT ISCHEMIC CHANGES. CORONARY ANGIOGRAPHY REVEALED A LONG STENOSIS IN THE PROXIMAL TO MEDIAL SEGMENT OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A NON-BSC GUIDEWIRE WAS INSERTED INTO THE DISTAL LAD AND THE LESION IN THE PROXIMAL TO MIDDLE SEGMENTS WAS DILATED USING A 2.0X20MM NON-BSC BALLOON. 2.5X28MM AND 3.0X16MM PROMUS ELEMENT STENTS WERE PLACED IN THE MEDIAL AND PROXIMAL LESIONS, RESPECTIVELY, FOLLOWED BY POST-DILATION WITH A 3.5X12MM NON-BSC BALLOON. SLIGHT COMPRESSION RESISTANCE OCCURRED WHEN THE BALLOON WAS FIRST INTRODUCED INTO THE LAD BECAUSE THE HEAD END OF THE BALLOON REACHED THE OPENING OF THE PROXIMAL STENT. AT THIS POINT, THE BALLOON HAD TO BE WITHDRAWN AND THE GUIDEWIRE POSITION WAS SLIGHTLY ADJUSTED SO THAT ANOTHER BALLOON COULD BE CAREFULLY MANEUVERED PAST THE PROXIMAL STENT WITHOUT DIFFICULTY. THE OVERLAPPING STENTS WERE THEN POST-DILATED AND EXAMINED BY RADIOGRAPHY. THE RESULTS DEMONSTRATED STENT MALAPPOSITION IN THE PROXIMAL LAD AND LONGITUDINAL STENT COMPRESSION AT THE OPENING WITH SHORTENING ON ONE SIDE AND CURLED UPWARD ON THE OTHER SIDE. AN INTRAVENOUS ULTRASOUND (IVUS) CATHETER WAS ALSO INSERTED INTO THE STENT. THE IVUS EXAMINATION ALSO REVEALED OVERLAPPING AT THE OPENING OF THE PROXIMAL STENT AND POOR STENT ADHERENCE. AFTER DILATION USING A 3.5X8MM NON-BSC BALLOON INFLATED TO 20 ATM, ANGIOGRAPHY SHOWED THAT THE LONGITUDINAL STENT COMPRESSION WAS MARKEDLY IMPROVED AS EVIDENCED BY A TIMI-3 FLOW. A SECOND IVUS EXAMINATION INDICATED THAT THE OVERLAPPING AT THE OPENING OF THE PROXIMAL STENT WAS IMPROVED AND THE STENTS WERE WELL ADHERED. THE PATIENT DID NOT HAVE ANY ADVERSE SYMPTOMS SUCH AS CHEST PAIN DURING THE SURGERY. AT FIVE DAYS AFTER SURGERY, THE PATIENT WAS DISCHARGED. THE PATIENT COMPLAINED OF NO DISCOMFORT DURING THE ONE YEAR FOLLOW-UP PERIOD. LONGITUDINAL STENT COMPRESSION IS A RARE PHENOMENON THAT MAY OCCUR DURING THE IMPLANTATION OF THIN CYLINDRICAL STENTS, ESPECIALLY PROMUS STENTS, PROBABLY BECAUSE OF THEIR DESIGN AND HIGH RADIOOPACITY. SUCH COMPRESSION MAY BE PREVENTED BY GENTLE AND CAREFUL BALLOON MANEUVERABILITY AND IMPROVED WITH THE USE OF ADDITIONAL BALLOON ANGIOPLASTY OR STENT IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564289 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY UNK634

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention