BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS¿ ELEMENT¿ LONG

    MDR report key: 3021636 · Received March 26, 2013

    Report

    Report Number
    2134265-2013-01772
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    June 16, 2011
    Report Date
    February 27, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH: (B)(6). (B)(6). DEVICE IS A COMBINATION PRODUCT (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS MDR ID#: 2134265-2013-01773, 2134265-2013-01774. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, MYOCARDIAL INFARCTION (MI) AND STENT MALPOSITION OCCURRED. IN (B)(6) 2011, THE PATIENT PRESENTED DUE TO STABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE 1ST LONG TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (PROX LAD) EXTENDING INTO DISTAL LAD WITH 80% STENOSIS AND WAS 50MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AND PLACEMENT OF TWO OVERLAPPING TAXUS ELEMENT STENTS OF SIZE 2.75X38MM AND 3.50X32MM, WITH 0% RESIDUAL STENOSIS FOLLOWING POST-DILATION. THE 2ND TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY (PROX LCX) WITH 80% STENOSIS AND WAS 12MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.2MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AND PLACEMENT OF A 3.5X16MM TAXUS ELEMENT STENT, WITH 0% RESIDUAL STENOSIS. ONE DAY POST INDEX PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN, TROPONIN VALUES WERE NOTED TO BE ELEVATED INDICATING AN MI. THE PATIENT DID NOT EXPERIENCE ISCHEMIC SYMPTOMS. MEDICATION WAS GIVEN TO TREAT THIS EVENT. THE EVENT WAS CONSIDERED RESOLVED WITH RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. TWO WEEKS LATER, THE PATIENT UNDERWENT CARDIAC CATHETERIZATION DUE TO PERSISTENT ANGINA SINCE PREVIOUS ADMISSION. CORONARY ANGIOGRAPHY SHOWED A TIGHT LESION IN THE DISTAL LCX AND A SMALL INTRALUMINAL DENSITY BETWEEN THE TWO STENTS IN THE LAD. IN JULY 2011, THE PATIENT PRESENTED FOR TREATMENT TO THE LCX AND INTRAVASCULAR ULTRASOUND EVALUATION OF THE LAD. ONE DAY LATER, THE PATIENT HAD ELEVATED CARDIAC ENZYMES INDICATING AN MI. THERE WAS 90% STENOSIS IN THE DISTAL LCX, WHICH WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A 2.5X16MM PROMUS STENT, WITH 0% RESIDUAL STENOSIS FOLLOWING POST-DILATION. INTRAVASCULAR ULTRASOUND SHOWED MALPOSITION OF THE DISTAL STENT IN THE LAD WHICH "DOES NOT APPEAR TO BE CRITICAL AND DOES NOT REQUIRE ANOTHER ANGIOPLASTY PROCEDURE." THE PATIENT DID NOT EXPERIENCE ISCHEMIC SYMPTOMS. NO OTHER ACTION WAS TAKEN TO TREAT THIS EVENT. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123820 TAXUS¿ ELEMENT¿ LONG CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493902538270 13612371

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R