BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1894930 · Received November 10, 2010

    Report

    Report Number
    2134265-2010-04905
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    June 2, 2010
    Report Date
    October 11, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(6). 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 RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED MYOCARDIAL INFARCTION AND UNDERWENT TARGET VESSEL REINTERVENTION. LESION 1 WAS A LONG LESION LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) AND EXTENDING TO THE DISTAL RCA. THE LESION WAS 85% STENOSED, 3.5MM IN DIAMETER AND 28MM LONG. THE LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF A 3.5X32MM TAXUS LIBERTE STENT. RESIDUAL STENOSIS WAS 0%. LESION 2 WAS LOCATED IN THE PROXIMAL RCA. THE LESION WAS 70% STENOSED, 3.5MM IN DIAMETER AND 6MM LONG. THE LESION WAS TREATED WITH DIRECT STENT PLACEMENT USING A 3.5X8MM TAXUS LIBERTE STENT. RESIDUAL STENOSIS WAS 0%. LESION 3 WAS A LONG LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) AND EXTENDING TO THE DISTAL LAD. THE LESION WAS 70% STENOSED, 2.75MM IN DIAMETER AND 12MM LONG. THE LESION WAS TREATED WITH DIRECT STENT PLACEMENT USING A 2.75X32MM TAXUS LIBERTE STENT. POST DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 0%. LESION 4 WAS LOCATED IN THE 1ST DIAGONAL. THE LESION WAS 90% STENOSED, 2.25MM IN DIAMETER AND 21MM LONG. THE LESION WAS TREATED WITH DIRECT STENT PLACEMENT AND PLACEMENT OF A 2.25 X24MM TAXUS LIBERTE STENT. POST DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 0%. IT WAS ALSO NOTED THAT A 99% LESION IN THE 1ST DIAGONAL WAS TREATED WITH SUCCESSFUL BALLOON ANGIOPLASTY. RESIDUAL STENOSIS WAS 30%. THE PATIENT WAS DISCHARGED 1 DAY LATER ON ASPIRIN AND PRASUGREL. IN JUNE 2010, 9 DAYS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION AND UNDERWENT TARGET VESSEL REINTERVENTION. THE PATIENT PRESENTED WITH A SEVERAL DAY HISTORY OF UNSTABLE ANGINA. AN ELECTROCARDIOGRAM SHOWED NORMAL SINUS RHYTHM AND TROPONIN WAS 0.16. CARDIAC CATHETERIZATION WAS RECOMMENDED. FOLLOWING CARDIAC CATHETERIZATION, TROPONIN PEAKED AT 4.16. NO ISCHEMIC ELECTROCARDIOGRAM CHANGES WERE NOTED. IT WAS NOTED THAT THE PATIENT DID HAVE SOME CHEST DISCOMFORT OVERNIGHT, HOWEVER, WAS ABLE TO WALK OVER A MILE IN THE HOSPITAL WITHOUT EXERTIONAL CHEST DISCOMFORT. A TARGET VESSEL REINTERVENTION WAS PERFORMED WITH TREATMENT TO THE 1ST DIAGONAL USING PREDILATION AND PLACEMENT OF A 3.0X15MM PROMUS STENT. FOLLOWING POST DILATION, RESIDUAL STENOSIS WAS 0%. A TARGET VESSEL REINTERVENTION WAS PERFORMED WITH TREATMENT TO THE MID LAD CONSISTING OF MULTIPLE BALLOON ANGIOPLASTIES. RESIDUAL STENOSIS WAS 0%. IT WAS NOTED THAT A RESTENOSIS OF A PREVIOUSLY PLACE STENT WAS REOPENED USING ANGIOPLASTY. A TARGET VESSEL REINTERVENTION WAS PERFORMED WITH PLACEMENT OF A 4.0X23MM PROMUS STENT TO THE LMCA DUE TO DISSECTION. RESIDUAL STENOSIS WAS 0%. A DISSECTION OF THE LCX WAS ALSO NOTED THAT WAS NOT TREATED AT THIS TIME. THE PROCEDURE WAS COMPLETED WITHOUT RESIDUAL EFFECTS. THE PATIENT WAS DISCHARGED 2 DAYS LATER ON ASPIRIN AND PRASUGREL.

    Description of Event or Problem · 1

    (B)(6). SAME CASE AS: 2134265-2010-04906, 2134265-2010-04907, 2134265-2010-04908. IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED MYOCARDIAL INFARCTION AND UNDERWENT TARGET VESSEL REINTERVENTION. LESION 1 WAS A LONG LESION LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) AND EXTENDING TO THE DISTAL RCA. THE LESION WAS 85% STENOSED, 3.5MM IN DIAMETER AND 28MM LONG. THE LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF A 3.5X32MM TAXUS LIBERTE STENT. RESIDUAL STENOSIS WAS 0%. LESION 2 WAS LOCATED IN THE PROXIMAL RCA. THE LESION WAS 70% STENOSED, 3.5MM IN DIAMETER AND 6MM LONG. THE LESION WAS TREATED WITH DIRECT STENT PLACEMENT USING A 3.5X8MM TAXUS LIBERTE STENT. RESIDUAL STENOSIS WAS 0%. LESION 3 WAS A LONG LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) AND EXTENDING TO THE DISTAL LAD. THE LESION WAS 70% STENOSED, 2.75MM IN DIAMETER AND 12MM LONG. THE LESION WAS TREATED WITH DIRECT STENT PLACEMENT USING A 2.75X32MM TAXUS LIBERTE STENT. POST DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 0%. LESION 4 WAS LOCATED IN THE 1ST DIAGONAL. THE LESION WAS 90% STENOSED, 2.25MM IN DIAMETER AND 21MM LONG. THE LESION WAS TREATED WITH DIRECT STENT PLACEMENT AND PLACEMENT OF A 2.25 X24MM TAXUS LIBERTE STENT. POST DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 0%. IT WAS ALSO NOTED THAT A 99% LESION IN THE 1ST DIAGONAL WAS TREATED WITH SUCCESSFUL BALLOON ANGIOPLASTY. RESIDUAL STENOSIS WAS 30%. THE PATIENT WAS DISCHARGED 1 DAY LATER ON ASPIRIN AND PRASUGREL. IN (B)(6) 2010, (B)(6) POST INDEX PROCEDURE, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION AND UNDERWENT TARGET VESSEL REINTERVENTION. THE PATIENT PRESENTED WITH A SEVERAL DAY HISTORY OF UNSTABLE ANGINA. AN ELECTROCARDIOGRAM SHOWED NORMAL SINUS RHYTHM AND TROPONIN WAS 0.16. CARDIAC CATHETERIZATION WAS RECOMMENDED. FOLLOWING CARDIAC CATHETERIZATION, TROPONIN PEAKED AT 4.16. NO ISCHEMIC ELECTROCARDIOGRAM CHANGES WERE NOTED. IT WAS NOTED THAT THE PATIENT DID HAVE SOME CHEST DISCOMFORT OVERNIGHT, HOWEVER, WAS ABLE TO WALK OVER A MILE IN THE HOSPITAL WITHOUT EXERTIONAL CHEST DISCOMFORT. A TARGET VESSEL REINTERVENTION WAS PERFORMED WITH TREATMENT TO THE 1ST DIAGONAL USING PREDILATION AND PLACEMENT OF A 3.0X15MM PROMUS STENT. FOLLOWING POST DILATION, RESIDUAL STENOSIS WAS 0%. A TARGET VESSEL REINTERVENTION WAS PERFORMED WITH TREATMENT TO THE MID LAD CONSISTING OF MULTIPLE BALLOON ANGIOPLASTIES. RESIDUAL STENOSIS WAS 0%. IT WAS NOTED THAT A RESTENOSIS OF A PREVIOUSLY PLACE STENT WAS REOPENED USING ANGIOPLASTY. A TARGET VESSEL REINTERVENTION WAS PERFORMED WITH PLACEMENT OF A 4.0X23MM PROMUS STENT TO THE LMCA DUE TO DISSECTION. RESIDUAL STENOSIS WAS 0%. A DISSECTION OF THE LCX WAS ALSO NOTED THAT WAS NOT TREATED AT THIS TIME. THE PROCEDURE WAS COMPLETED WITHOUT RESIDUAL EFFECTS. THE PATIENT WAS DISCHARGED (B)(6) LATER ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention TAXUS LIBERTE 2.75X32MM STENT| TAXUS LIBERTE 2.25X24MM STENT| TAXUS LIBERTE 3.50X8MM STENT