BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS VASCULAR LD PREMOUNTED STENT SYSTEM

    MDR report key: 1873167 · Received October 18, 2010

    Report

    Report Number
    2134265-2010-04552
    Event Type
    Injury
    Date Received
    October 18, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 22, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED IN TWO SECTIONS AS RESULT OF A BREAK IN THE SHAFT AT THE PROXIMAL BALLOON BOND AREA. VISUAL AND TACTILE ANALYSIS REVEALED THE SHAFT PROXIMAL TO THE BREAK WAS SEVERELY STRETCHED FOR APPROXIMATELY 92MM IN LENGTH. A KINK WAS NOTED 450MM DISTAL TO THE STRAIN RELIEF. THE BALLOON WAS NOT FOLDED OR WRAPPED AROUND THE SHAFT OF THE DEVICE. DUE TO THE BALLOON DETACH, IT IS NOT POSSIBLE TO TEST THE BALLOON FOR LEAKS. THERE WERE TRACES OF BLOOD PRESENT INSIDE THE BALLOON. THERE WAS NO STENT ON THE BALLOON. FROM THE CONDITION OF THE BALLOON IT WAS NOT POSSIBLE TO SEE A CLEAR IMPRESSION OF WHERE THE STENT WAS ORIGINALLY CRIMPED ON TO THE BALLOON. THE DAMAGE NOTED IS CONSISTENT WITH THE DEVICE BEING PULLED ON WITH FORCE IN ORDER TO REMOVE THE DEVICE FROM THE PATIENT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFG# 2134265-2010-04553. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, REMOVAL DIFFICULTIES, BALLOON DETACHMENT AND SHAFT BREAK OCCURRED. THE 80-90% STENOSED ECCENTRIC LESION WAS LOCATED IN A VERY CALCIFIED AND SEVERELY TORTUOUS COMMON ILIAC ARTERY. AN UNSPECIFIED ZIPWIRE GUIDE WIRE WAS ADVANCED WITH EXTREME DIFFICULTY INTO THE STENOSIS OF THE ILIAC ARTERY. DUE TO THE RESISTANCE IN THE VESSEL, THE PHYSICIAN DECIDED TO USE THE BACK-UP MEIER GUIDE WIRE. THEN, WITHOUT PRE-DILATATION, THE PHYSICIAN ADVANCED WITH GREAT DIFFICULTY THE 10.0X60X75CM EXPRESS VASCULAR LD PREMOUNTED STENT DELIVERY SYSTEM INTO THE LESION. THE STENT WAS INFLATED USING A NON-BSC INFLATION DEVICE BUT, THE PHYSICIAN SOON DETECTED A PRESSURE LOSS AND THE STENT COULD ONLY BE PARTIALLY INFLATED TO 7 ATMS. UPON REMOVAL OF THE DEVICE BALLOON WITHDRAWAL DIFFICULTIES OCCURRED. SEVERE FORCE WAS APPLIED DURING REMOVAL AND SUBSEQUENTLY THE BALLOON DETACHED. THE ANATOMICAL LOCATION OF THE BALLOON IS UNIDENTIFIED AND THE BALLOON REMAINS INSIDE THE PATIENT'S ANATOMY. NEXT, A 9.0X60X75CM EXPRESS LD PREMOUNTED STENT DELIVERY SYSTEM WAS SELECTED AND, DURING ADVANCEMENT, ENCOUNTERED DIFFICULTY. THE PHYSICIAN PLACED THE 9.0X60X75CM STENT UNDERNEATH THE ALREADY POSITIONED 10.0X60X75CM STENT, SUCCESSFULLY INFLATING AND FULLY APPOSING THE STENT TO THE VESSEL WALL. AGAIN, WITHDRAWING THE BALLOON CATHETER WAS EXTREMELY DIFFICULT AND DURING THE WITHDRAWAL ATTEMPT WITH THE FORCE APPLIED THE BALLOON DETACHED FROM THE SHAFT AND A SHAFT "RUPTURE" OCCURRED. THE BALLOON WAS SUCCESSFULLY RETRIEVED WITH FORCEPS. THE PROCEDURE WAS COMPLETED. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS LISTED AS STABLE.

    Description of Event or Problem · 1

    SAME CASE AS MFG# 2134265-2010-04553. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, REMOVAL DIFFICULTIES, BALLOON DETACHMENT AND SHAFT BREAK OCCURRED. THE 80-90% STENOSED ECCENTRIC LESION WAS LOCATED IN A VERY CALCIFIED AND SEVERELY TORTUOUS COMMON ILIAC ARTERY. AN UNSPECIFIED ZIPWIRE GUIDE WIRE WAS ADVANCED WITH EXTREME DIFFICULTY INTO THE STENOSIS OF THE ILIAC ARTERY. DUE TO THE RESISTANCE IN THE VESSEL, THE PHYSICIAN DECIDED TO USE THE BACK-UP MEIER GUIDE WIRE. THEN, WITHOUT PRE-DILATATION, THE PHYSICIAN ADVANCED WITH GREAT DIFFICULTY THE 10.0X60X75CM EXPRESS VASCULAR LD PREMOUNTED STENT DELIVERY SYSTEM INTO THE LESION. THE STENT WAS INFLATED USING A NON-BSC INFLATION DEVICE BUT, THE PHYSICIAN SOON DETECTED A PRESSURE LOSS AND THE STENT COULD ONLY BE PARTIALLY INFLATED TO 7 ATMS. UPON REMOVAL OF THE DEVICE BALLOON WITHDRAWAL DIFFICULTIES OCCURRED. SEVERE FORCE WAS APPLIED DURING REMOVAL AND SUBSEQUENTLY THE BALLOON DETACHED. THE ANATOMICAL LOCATION OF THE BALLOON IS UNIDENTIFIED AND THE BALLOON REMAINS INSIDE THE PATIENT'S ANATOMY. NEXT, A 9.0X60X75CM EXPRESS LD PREMOUNTED STENT DELIVERY SYSTEM WAS SELECTED AND DURING ADVANCEMENT ENCOUNTERED DIFFICULTY. THE PHYSICIAN PLACED THE 9.0X60X75CM STENT UNDERNEATH THE ALREADY POSITIONED 10.0X60X75CM STENT, SUCCESSFULLY INFLATING AND FULLY APPOSING THE STENT TO THE VESSEL WALL. AGAIN WITHDRAWING THE BALLOON CATHETER WAS EXTREMELY DIFFICULT AND DURING THE WITHDRAWAL ATTEMPT WITH THE FORCE APPLIED THE BALLOON DETACHED FROM THE SHAFT AND A SHAFT "RUPTURE" OCCURRED. THE BALLOON WAS SUCCESSFULLY RETRIEVED WITH FORCEPS. THE PROCEDURE WAS COMPLETED. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS LISTED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS VASCULAR LD PREMOUNTED STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74938162960750 0013654385

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention GUIDE WIRE, MEIER| GUIDE WIRE, ZIPWIRE| STENT: EXPRESS VASCULAR 10X60X75