BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1823113 · Received September 1, 2010

    Report

    Report Number
    2134265-2010-04045
    Event Type
    Injury
    Date Received
    September 1, 2010
    Date of Event
    July 15, 2010
    Report Date
    August 5, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).DEVICE IS A COMBINATION PRODUCT.DEVICE EVALUATED BY MANUFACTURER - 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED DURING THE INDEX IN (B)(6) 2010, THAT THE CARDIAC TROPONIN LEVELS WERE REPORTED AS NEGATIVE. CORONARY ANGIOGRAPHY REVEALED A TUBULAR 60% DIAMETER STENOSIS IN THE MID LAD, A TUBULAR 80% DIAMETER STENOSIS AT THE OSTIUM OF THE FIRST DIAGONAL BRANCH, AND A TUBULAR 80% DIAMETER STENOSIS AT THE PROXIMAL PORTION OF THE 2ND DIAGONAL BRANCH. A WIRE WAS SUBSEQUENTLY PASSED THROUGH THE MID LAD AND PTCA WAS PERFORMED TO THE MID LAD LESION WITH BALLOON INFLATIONS AT 8 ATM FOR 10 SECONDS. A KISSING BALLOON TECHNIQUE WAS UTILIZED TO DILATE THE LAD AND DIAGONAL BRANCH. HOWEVER, THE PHYSICIAN ELECTED, DUE TO THE PATIENTS' HISTORY OF RENAL TRANSPLANT, NO INTERVENTION WAS PERFORMED TO THE FIRST DIAGONAL AS THE PATIENT WILL CONTINUE ON MEDICAL THERAPY.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT DURING THE INDEX PROCEDURE IN (B)(6) 2010, THE PATIENT EXPERIENCED DIMINISHED BLOOD FLOW AFTER THE PLACEMENT OF THE FIRST STENT. THIS CAUSED AN INCREASED COMPROMISE TO THE MID LAD. THE PHYSICIAN IMPLANTED THE SECOND STENT WITH GOOD ANGIOGRAPHIC RESULT AND THE DIMINISHED BLOOD FLOW THROUGH THE MID LAD WAS RESOLVED.

    Description of Event or Problem · 1

    (B)(6) CLINICAL STUDY. SAME PATIENT AS: 2134265-2010-04116. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED A POSITIVE STRESS TEST AND ANGINA LESION 1 WAS LOCATED IN THE 2ND DIAGONAL. THE LESION WAS TREATED WITH THE PLACEMENT OF A 2.25X12MM TAXUS LIBERTE ATOM STENT. LESION 2 WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD). THE LESION WAS TREATED WITH THE PLACEMENT OF A 2.5X18MM NON-BSC STENT. POST PROCEDURE RESIDUAL STENOSIS WAS 0% WITH TIMI 3 FLOW NOTED. THE PATIENT LATER RECEIVED A PERI-PROCEDURAL LOADING DOSE OF CLOPIDOGREL (600 MG) AND WAS STARTED ON ASPIRIN (325 MG) DOSAGE. THE PATIENT WAS DISCHARGED 1 DAY LATER ON 75 MG DOSAGE OF CLOPIDOGREL. IN (B)(6) 2010, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR AN ELECTIVE CARDIAC CATHETERIZATION FOLLOWING A POSITIVE STRESS TEST. REPEAT PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED WITH THE PLACEMENT OF TWO DRUG ELUTING STENTS. LESION 1 WAS LOCATED IN THE 1 DIAGONAL. THE LESION WAS TREATED WITH THE PLACEMENT OF A 2.25X8MM TAXUS LIBERTE ATOM STENT. LESION 2 WAS LOCATED IN THE PROXIMAL LAD. THE LESION WAS TREATED WITH THE PLACEMENT OF A 2.5X18MM NON-BSC STENT. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS DISCHARGED 1 DAY LATER IN STABLE CONDITION. IN (B)(6) 2010, THE PATIENT EXPERIENCED CHEST PAIN AND ANGINA. THE PATIENT WAS PRESENTED TO THE EMERGENCY ROOM WITH SUBSTERNAL CHEST PAIN AT REST SINCE THE LEFT HEART CATHETERIZATION. THE PATIENT'S ADMITS THAT HER ANXIETY LIKELY CONTRIBUTES TO CHEST PAIN AND THEREFORE SHE TOOK AN ATIVAN, HOWEVER, THE PAIN PERSISTED, AND SHE WENT TO EMERGENCY DEPARTMENT FOR FURTHER EVALUATION.' ELECTROCARDIOGRAM (EKG) WAS UNCHANGED AND INITIAL TROPONIN WAS NEGATIVE. THE PATIENT WAS STARTED ON HEPARIN FOR UNSTABLE ANGINA. THE PATIENT WAS LATER TAKEN TO THE CATH LAB FOR LEFT HEART CATHETERIZATION. CATHETERIZATION REVEALED PATENT STENTS AND NO NEW FLOW-LIMITING DISEASE. THE LEFT ANTERIOR DESCENDING HAD WIDELY PATENT STENTS WHICH CROSS A SMALL FIRST AND SECOND DIAGONAL BRANCH. THE FIRST DIAGONAL BRANCH HAD OSTIAL 50% IN-STENT RESTENOSIS AND 30% IN-STENT RESTENOSIS IN THE 2ND DIAGONAL. THE PAROXYSMAL CHEST PAIN WAS THOUGHT TO BE DUE TO CORONARY SPASM, ESPECIALLY AROUND THE SITE OF THE PRIOR STENTS GIVEN THE SMALL CALIBER VESSELS AND PRIOR LARGE STENTS. THE PATIENT WAS STARTED ON ISOSORBIDE MONONITRATE FOR ANGINA AND HER ATENOLOL WAS TITRATED DOWN TO 25MG DAILY SO THAT THE PATIENT'S BLOOD PRESSURE COULD TOLERATE. NO PATENT COMPLICATIONS WERE NOTED AND THE PATIENT'S STATUS IS STABLE. THE PATIENT WAS DISCHARGED 1 DAY LATER ON ASPIRIN, ATENOLOL, ATORVASTATIN, BUPROPION, CLOPIDOGREL, ESZOPICLONE, EZETIMIBE, ISOSORBIDE MONONITRATE, LORAZEPAM, MYCOPHENOLATE MOFETILM NIACIN AND NITROGLYCERIN.

    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 H7493893612220 0013399080

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R 2.5X18 XIENCE STENT