BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM

    MDR report key: 1021257 · Received March 28, 2008

    Report

    Report Number
    2134265-2008-00906
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    September 1, 2007
    Report Date
    March 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; 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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS #2134265-2008-00901, 00902, 00903, 00904, 00905, 00908. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A DISSECTION OCCURRED AND POST PROCEDURE, RESTENOSES OCCURRED. THE PT INITIALLY PRESENTED WITH AN ACUTE MI WITH ST ELEVATIONS IN 2007. AN EMERGENT ANGIOGRAPHY WAS PERFORMED REVEALING THREE VESSEL DISEASE. THE LEFT ANTERIOR DESCENDING (LAD) ARTERY HAD A SUBTOTAL OCCLUSION WITH PLAQUE ABOUT 6-7CM IN LENGTH. THERE WERE SEVERAL 90-95% STENOSES THROUGHOUT THE CIRCUMFLEX (CX) AND 1ST AND 2ND OBTUSE MARGINAL (OM1 & OM2) ARTERIES. THE OSTIAL RIGHT CORONARY ARTERY (RCA) WAS 75% STENOSED AND THE PROXIMAL TO MID RCA WAS 99% STENOSED. A SURGICAL CONSULT WAS OBTAINED; HOWEVER, IT WAS FELT THAT THE PT WAS NOT A GOOD CANDIDATE FOR BYPASS SURGERY DUE TO HER VERY YOUNG AGE AND VERY POOR TARGETS IN THE DISTAL VESSEL WITH DISTAL DIABETIC VASCULAR DISEASE. THEREFORE, THE PHYSICIAN OPTED TO TREAT THE TARGET LESIONS. THE STENTS WERE PLACED AS FOLLOWS: TAXUS EXPRESS2 2.75X32MM DRUG ELUTING STENT IN THE DISTAL TO MID RCA, TAXUS EXPRESS2 3.0X32MM DRUG ELUTING STENT IN THE PROXIMAL TO MID RCA, TAXUS EXPRESS2 3.5X12MM DRUG ELUTING STENT IN THE PROXIMAL TO OSTIAL RCA, A TAXUS EXPRESS2 2.75X32MM DRUG ELUTING STENT IN THE DISTAL LAD, A TAXUS EXPRESS2 2.75X12MM DRUG ELUTING STENT OVERLAPPING IN THE MID LAD AND FINALLY A TAXUS EXPRESS2 3.0X32MM DRUG ELUTING STENT IN THE PROXIMAL LAD. THE PROCEDURE WAS COMPLICATED BY AN EXTENSIVE DISSECTION IN THE LAD, WHICH WAS TREATED WITH BALLOON ANGIOPLASTY AND NOT STENTED TO AVOID COMPLETE METAL JACKET IN THE LAD. THE PT WAS IN CARDIOGENIC SHOCK AT THE TIME AND SUBSEQUENTLY RECOVERED. IN 2007, THE PT PRESENTED WITH RECURRENT STABLE ANGINA. ANGIOGRAPHY REVEALED SEVERE RESTENOSIS IN THE DISTAL/APICAL LAD AND BEYOND THE STENTED SEGMENT WITH 99% STENOSIS. THE VESSEL LOOKED ATRETIC. TWO NON-BSC STENTS WERE PLACED IN THE OM1 AND ANOTHER NON-BSC STENT WAS PLACED IN THE OM2. PTCA OF THE APICAL LAD WAS PERFORMED; HOWEVER, STENTING WAS NOT DONE DUE TO THE SMALL SIZE OF THE APICAL LAD. IN TWO MONTHS LATER, THE PT PRESENTED AGAIN WITH RECURRENT CHEST PAIN. A NON-BSC STENT WAS PLACED IN THE MID LAD INSIDE A PREVIOUSLY IMPLANTED TAXUS EXPRESS2 STENT THAT HAD RESTENOSED AND PTCA WAS PERFORMED IN THE DISTAL LAD WITH A 2.5X15MM MAVERICK BALLOON FOR RESTENOSIS IN THE NON-STENTED DISTAL/APICAL SEGMENT. THE PT PRESENTED LATER THAT SAME MONTH WITH RECURRENT CHEST PAIN. THE PHYSICIAN PERFORMED ANGIOPLASTY WITH A CUTTING BALLOON FOR IN-STENT RESTENOSIS (ISR) IN THE CX AND OM1. THE OM2 HAD 70-80% ISR AND THE RCA HAD 30-40% ISR. ONLY PTCA WAS PERFORMED. SIX WEEKS LATER THE PT PRESENTED AGAIN WITH RECURRENT STABLE ANGINA. A TAXUS EXPRESS2 2.5X16MM DRUG ELUTING STENT WAS PLACED IN THE OM1 AND A TAXUS EXPRESS2 2.75X20MM DRUG ELUTING STENT WAS PLACED IN AN OVERLAPPING FASHION FROM OM1 TO THE CX ARTERY FOR TREATMENT OF ISR. OM2 WAS TREATED WITH A KISSING BALLOON ANGIOPLASTY. ADEQUATE RESULTS WERE ACHIEVED. DESPITE ALL THESE INTERVENTIONS, THE PT HAS NEVER EXPERIENCED ANY SIGNIFICANT PAIN RELIEF. BECAUSE THE LAD WAS VERY SMALL AND SEVERELY DISEASED, SPECIAL PERMISSION WAS OBTAINED FOR COMPASSIONATE USE OF 2.25MM TAXUS ELEMENT STENTS. ABOUT 3 WEEKS LATER, THE PT WAS ADMITTED AFTER TAKING THREE NTG WITHOUT RELIEF OF CHEST PRESSURE AND PAIN. SHE RETURNED TO THE CCL. A 2.0X30MM MAVERICK2 BALLOON WAS INFLATED "GENTLY TO ONLY 2-4 ATM'S ALONG THE ENTIRE SEGMENT" WHICH RESULTED IN A DISSECTION OF THE APICAL SEGMENT. FLOW BECAME TIMI 0 AND THERE WAS A DISSECTION FLAP. CROSS HANG-UP INDICATED THAT THE TIP OF THE WIRE WAS NOT IN AN INTRALUMINAL POSITION. THE GUIDE WIRE WAS REMOVED FROM THE DISSECTION PLANE AND AN OTW BALLOON WAS PLACED IN THE DISTAL/APICAL LAD. CONTRAST INJECTION THEN DEMONSTRATED THE LOCATION OF THE TRUE LUMEN. A CHOICE PT GUIDE WIRE WAS THEN PLACED VIA THE OTW MAVERICK BALLOON, AND AFTER SOME EFFORT, WAS PLACED INTO THE TRUE LUMEN. PTCA WAS AGAIN REPEATED WITH A 1.5MM BALLOON. MINIMAL FLOW WAS ESTABLISHED. THE DISSECTION WAS SO EXTENSIVE, THAT THERE WAS NO ANTEGRADE FLOW WITHOUT STENTING. THEREFORE, THREE OVERLAPPING TAXUS ELEMENT STENTS WERE DEPLOYED FROM THE VERY APICAL PORTION OF THE LAD UP TO THE DISTAL LAD. FOLLOWING IMPLANTATION OF THE THREE STENTS, THE FLOW WAS INITIALLY SLUGGISH. THE STENTED SEGMENTS LOOKED HAZY. A 2.25MM QUANTUM MAVERICK BALLOON WAS USED TO POST DILATE. WHEN THE WIRE WAS REMOVED, ANGIOGRAPHY DEMONSTRATED LAD WAS WIDELY PATENT WITH NORMAL TIMI 3 FLOW. ESSENTIALLY THE ENTIRE LAD HAD BEEN STENTED UP TO THE APEX OF THE ANTERIOR WALL. ONLY THE VERY DISTAL PORTION OF THE INFERIOR APICAL SEGMENT OF THE LAD HAD NOT BEEN STENTED. THERE WAS MILD RESIDUAL DISSECTION, BUT THE FLOW WAS TIMI 3. THIS SEGMENT WAS TOO SMALL TO STENT EVEN WITH A 2.25MM STENT. THE PT TOLERATED THE PROCEDURE VERY WELL AND HAD NO CHEST PAIN OR EKG CHANGES. THE PT CONTINUED TO COMPLAIN OF ONGOING CHEST PAIN FOLLOWING THE PROCEDURE, WHICH WORSENED WITH ACTIVITY. THE PT DID NOT EXHIBIT ANY FURTHER ISCHEMIC CHANGES, EKG CHANGES AND NO TROPONIN CHANGES. THE PT ATTEMPTED CARDIAC REHAB AND HAD LIMITED RESULTS DUE TO CHEST PAIN SYMPTOMS. ADJUSTMENTS TO THE CARDIAC MEDICATIONS WERE MADE AND A NEW MEDICATION WAS INITIATED, HOWEVER, THE PT DID NOT SHOW ANY IMPROVEMENT OF SYMPTOMS. MS CONTIN AND IV MORPHINE WERE ADMINISTERED WITHOUT RELIEF OF SYMPTOMS. LONG ACTING MORPHINE WAS STARTED; HOWEVER, THE PT HAD VERY MINIMAL SYMPTOM RELIEF. ANOTHER MEDICATION WAS STARTED FOR NEUROPATHIC PAIN AND A PAIN CONSULT WAS ORDERED. FIVE DAYS POST PROCEDURE THE PT WAS DISCHARGED. THE PT HAD PREVIOUSLY BEEN UNDERGOING EECP THERAPY HOWEVER, THIS WAS SUSPENDED IN ORDER TO EVALUATE THE NEUROPATHIC PAIN. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC 3.0X32MM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention