BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS 2 (R)

    MDR report key: 2061266 · Received April 18, 2011

    Report

    Report Number
    2134265-2011-01194
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 21, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P020009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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, THE PATIENT ALLEGES HE WAS TOLD BY TWO ER DOCTORS THAT THERE IS BLOOD PRESSURE MEDICATION ON HIS TAXUS LIBERTE ATOM STENT AND TAXUS LIBERTE LONG STENT. PATIENT IS HAVING TROUBLE REGULATING HIS BLOOD PRESSURE. THE PATIENT IS CONCERNED THAT THE POLYMER IS NOT BIODEGRADABLE AND THAT NO STUDIES IDENTIFY ANY INTERACTIONS WITH OTHER DRUGS. THE PATIENT HAS HAD PROBLEMS WITH HIS BLOOD PRESSURE GOING VERY LOW; HISTORICALLY HE HAD HIGH BLOOD PRESSURE. THE PATIENT'S BLOOD PRESSURE IS "TOO LOW FOR HIM TO TAKE NITRO AND FOR IT TO BENEFIT HIM". THE PATIENT STATES THAT PRIOR TO STENT PLACEMENT IN (B)(6) 2011, HE HAD AN INFECTION. THE PATIENT THINKS THAT WHEN THE TAXUS LIBERTE STENTS WERE IMPLANTED THIS LOWERED HIS IMMUNITY AND THE BENEFIT OF THE ANTIBIOTICS THUS PROLONGING HIS INFECTION. THE PATIENT IS STILL TAKING ANTIBIOTICS TODAY FOR THE INFECTION.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED ON MAUDE EVENT REPORT: (B)(4), THAT THE PATIENT BEGAN EXPERIENCING CHEST PAINS ON (B)(6), 2011.

    Description of Event or Problem · 1

    SAME CASE AS MFR#: 2134265-2011-01195 AND 2134265-2011-01196. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, RESTENOSIS, ANGINA, AND HYPERSENSITIVITY OCCURRED. IN (B)(6) 2010, THE PATIENT PRESENTED WITH ANGINA AND CAROTID STENOSIS BY DUPLEX. ACCESS WAS OBTAINED THROUGH THE RIGHT FEMORAL ARTERY. THE 90% STENOSED TUBULAR LESION BEING TREATED WAS LOCATED IN THE NON-TORTUOUS MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS PREDILATED WITH A 2.0X15MM APEX BALLOON, INFLATED TO 6.3ATM FOR 9 SECONDS. THE PHYSICIAN DEPLOYED A 2.5X20MM EXPRESS2 STENT, INFLATED TO 18.5ATM FOR 9 SECONDS. ANGIOGRAPHY PERFORMED AND STENT WAS WELL APPOSED. STENOSIS WAS REDUCED TO 0%. MEDICATIONS GIVEN INCLUDED: ANGIOMAX, NITROGLYCERIN, AND PLAVIX. ON AN UNSPECIFIED DATE, THE PATIENT HAD AN UNKNOWN TYPE/MANUFACTURES STENT IMPLANTED IN THE HIP AREA BY A VASCULAR PHYSICIAN. WHEN THIS UNKNOWN STENT WAS IMPLANTED, THE PATIENT BEGAN EXPERIENCING HIS HANDS TURNING WHITE AND TINGLING DUE TO LOSS OF BLOOD FLOW. THE PATIENT WENT IN FOR A "DYE TEST" AND HEART CATH, WHICH REVEALED THE PREVIOUSLY IMPLANTED EXPRESS2 STENT HAD RESTENOSED. ON (B)(6), 2011, THE PATIENT PRESENTED WITH ANGINA. ACCESS WAS OBTAINED THROUGH THE RIGHT FEMORAL ARTERY. A 2.5X24MM TAXUS LIBERTE STENT WAS DEPLOYED IN THE MID RCA, INFLATED TO 18.5ATM FOR 18 SECONDS TO TREAT THE 75% IN-STENT RESTENOSED MID RCA. ANGIOGRAPHY WAS PERFORMED AND STENT WAS WELL APPOSED. THEN THE PHYSICIAN PREDILATED THE 70% MID CIRCUMFLEX (CX) WITH A 2.5X12MM APEX BALLOON, INFLATED TO 8.1ATM FOR 9 SECONDS. A 2.25X12MM TAXUS LIBERTE ATOM STENT WAS DEPLOYED, INFLATED TO 18.2ATM FOR 14 SECONDS. ANGIOGRAPHY WAS PERFORMED AND STENT WAS WELL APPOSED. MEDICATIONS GIVEN INCLUDED: ANGIOMAX. PATIENT HAS CONTINUED TO EXPERIENCE ANGINA AND FEELS HE IS HAVING AN "ALLERGIC ADVERSE EFFECT" FROM THE DRUG COATED STENTS. EXPERIENCING: ACID REFLUX, GI ISSUES, AND ARM PAIN ON (B)(6), 2011, THE PATIENT WAS ADMITTED TO THE HOSPITAL AFTER EXPERIENCING SEVERE CHEST PAINS THAT TURNED INTO A SEVERE BURNING SENSATION IN HIS CHEST AND UP AND DOWN BOTH ARMS. PATIENT STATED HIS "TESTS" WERE ALL OFF AND THE HOSPITAL IDENTIFIED HE HAD LOST HIS PULSE IN THE RIGHT ARM AND FOOT, AT WHICH POINT HE NOTICED THE NUMBNESS. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS PRESCRIBED NEXIUM AND REFERRED TO A GI PHYSICIAN. PATIENT WAS RELEASED THE FOLLOWING DAY. FOLLOWING THE PATIENTS DISCHARGE FROM THE HOSPITAL, HE DRANK A GATORADE, DUE TO THE TESTS BEING OFF, AND FELT DIZZY FOR DAYS. THE PATIENT REPORTED EXPERIENCING: DIZZY, BURNING IN HIS RECTUM, URINE SMELLS LIKE CHLORINE, BURNING IN THE BACK OF HIS EYES, CHEST PAIN, BLURRY VISION, FEELING CRAZY, AND ENTIRE BODY BURNING "LIKE WHEN HE HAD INTRON CHEMO". THE PATIENT IS WORRIED ABOUT HIS "KIDNEY, LIVER, AND OTHER ORGANS" AND HAS CONSIDERED DRINKING RUBBING ALCOHOL TO HELP REMOVE THE POLYMER/DRUG. THE PATIENT STATED HE IS GOING TO DO CHELATION AND LIKES TO STAY AWAY FROM AMERICAN MEDICINE. HAS HAD A RECENT NERVE CONDUCTION TEST, DUE TO NO FEELING IN RIGHT FOOT. THE IMPLANTING PHYSICIAN REPORTED THE PATIENT'S SYMPTOMS ARE PSYCHOSOMATIC.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT BELIEVES THE RELEASE OF THE PACLITAXEL DRUG HAS CAUSED CONGESTIVE HEART FAILURE; WHICH HE IS 'GOING IN AND OUT OF'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS 2 (R) STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493505020250 12902318

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention