BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX HERCULINK ELITE STENT SYSTEM

    MDR report key: 1867691 · Received October 8, 2010

    Report

    Report Number
    3004742046-2010-00468
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 15, 2010
    Manufacturer
    ABBOTT VASCULAR-TEMECULA-VS
    Product Code
    FGE
    PMA / PMN Number
    K063481
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HERCULINK ELITE (PART 1011487-15, LOT UNK) IS BEING FILED AS A SEPARATE MFR#. EVAL SUMMARY: STENT DISLODGEMENT CAN BE INFLUENCED BY MANY FACTORS, INCLUDING, BUT NOT LIMITED TO; IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, INCORRECT SHEATH SIZING, POSITIVE PRESSURE DURING PREP, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCE SHEATH REMOVAL, HANDLING OF THE STENT DURING PREP, INTERACTION WITH ACCESSORY DEVICES, INTERACTION WITH THE LESION, TORTUOUS ANATOMY, OR HEAVY CALCIFICATIONS. THE LESION SITE WAS DESCRIBED AS HEAVILY CALCIFIED WHICH MAY HAVE CONTRIBUTED TO THE REPORTED DISLODGEMENT. IT MAY BE POSSIBLE THAT THE STENT BECAME LODGED WITHIN THE PLAQUE DURING THE ATTEMPTS TO CROS AND DURING REMOVAL, THE STENT DISLODGED FROM THE BALLOON. ADD'L TREATMENT WAS NEEDED BY USING A SNARE DEVICE TO RETRIEVE THE DISLODGEMENT STENT. AS IT WAS REPORTED THAT THE HERCULINK ELITE WAS BEING USED TO TREAT THE RENAL ARTERY, IT SHOULD BE NOTED THAT THE PRODUCT INSTRUCTION FOR USE (IFU) STATES, "THE RX HERCULINK ELITE BILARY STENT SYSTEM IS INTENDED FOR PALLIATION OF MALIGNANT STRICTURES IN THE BILIARY TREE." IN THIS CASE, IT COULD NOT BE DETERMINED IF THE OFF-LABEL USE CAUSED OR CONTRIBUTED TO THE REPORTED STENT DISLODGEMENT. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT. W/O HAVING THE PRODUCT FOR EVAL, A CONCLUSIVE CAUSE FOR THE REPORTED STENT DISLODGEMENT COULD NOT BE DETERMINED. HOWEVER, THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY. ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT DAMAGE, STENT PLACEMENT/SECURITY AND DIMENSIONALLY INSPECTED TO VERIFY THE CRIMPED STENT OUTER DIAMETERS. ADDITIONALLY, A SAMPLING OF UNITS IS SUBJECTED TO A STENT MOVEMENT TEST TO VERIFY STENT SECURITY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL COVERED STENT WAS USED DURING AN ESOPHAGEAL STENTING PROCEDURE WITHIN A CANCER PATIENT ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A SIX TO SEVEN CENTIMETER LESION ALONG THE LOWER PART OF THE ESOPHAGUS. THE ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE DEPLOYMENT SUTURE BECAME STUCK ON THE STENT, LEAVING THE STENT ONLY PARTIALLY DEPLOYED. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT ISSUE, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX ESOPHAGEAL COVERED STENT. THERE WERE NO COMPLICATIONS TO THE PATIENT, AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATTEMPTED INTERVENTIONAL PROCEDURE OF THE RENAL ARTERY, THE 4.0X12 HERCULINK ELITE COULD NOT COMPLETELY CROSS THE TARGET LESION AND DURING REMOVAL, THE STENT DISLODGED AND REMAINED IN THE VESSEL PLAQUE. THE DISLODGED STENT WAS RETRIEVED WITH AN UNSPECIFIED SNARE DEVICE. THERE WAS NO REPORTED PT EFFECT. THE VESSEL WAS RE-WIRED AND A 4.0X15 HERCULINK ELITE WAS USED SUCCESSFULLY. IT WAS NOTED BY TWO PHYSICIANS VIEWING THE ANGIOGRAM THAT EITHER A DISSECTION OR A THROMBUS WAS DISTAL TO THE STENT, HOWEVER, WAS CONCLUDED TO BE THROMBUS. THE PT WAS GIVEN HEPARIN AND A THROMBECTOMY WAS ATTEMPTED. THE PT WAS REPORTEDLY IN STABLE CONDITION BUT THE PROCEDURE WAS CONTINUING AS THE PHYSICIANS WERE 'INTERVENING ON THE CLOT'. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX HERCULINK ELITE STENT SYSTEM BILIARY STENT SYSTEM FGE ABBOTT VASCULAR-TEMECULA-VS NA 0030154

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention UNSPECIFIED SNARE DEVICE| (#2) UNSPECIFIED GUIDE WIRE| HERCULINK ELITE (PART 1011487-15, LOT UNK)| HEPARIN| GUIDE WIRE: SPARATACORE