BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAF

    MDR report key: 2141618 · Received June 27, 2011

    Report

    Report Number
    3005099803-2011-02207
    Event Type
    Injury
    Date Received
    June 27, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 3, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    JCT
    PMA / PMN Number
    K012883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - THE REPORTED EVENT OF COMPONENT OF STENT CATHETER DETACHED. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    ONLY THE STENT DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS; THE STENT WAS IMPLANTED WITHIN THE PATIENT. A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE SILASTIC TUBING AT THE DISTAL END OF THE SHAFT WAS MISSING. THE SILASTIC TUBING WAS RECEIVED IN A SEPARATE VIAL/JAR. AN EXAMINATION OF THE TUBING FOUND NO TEARS OR OTHER ISSUES. NO ISSUES WERE FOUND WITH THE SHAFT OF THE STENT DELIVERY SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED BATCH. FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION FOR THIS EVENT IS UNDETERMINABLE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 3005099803-2011-02206 AND MFR. REPORT # 3005099803-2011-02207). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEMS WERE USED DURING A STENT PLACEMENT PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD NON-SMALL-CELL CARCINOMA WITH TUMOR INVASION INTO THE LEFT MAINSTEM BRONCHUS. THE STRICTURE WAS APPROXIMATELY 3CM IN LENGTH. THE ANATOMY WAS NOTED TO BE TORTUOUS; HOWEVER, THE STRICTURE WAS NOT DILATED PRIOR TO STENT PLACEMENT. THE PHYSICIAN ATTEMPTED A STIFF INTUBATION BUT WAS UNSUCCESSFUL DUE TO ANATOMIC CONDITIONS. INTUBATION WAS ACHIEVED USING A 8.0 RÖSCH TUBE. AN AMPLATZ GUIDEWIRE WAS INSERTED INTO THE LEFT UPPER LOBE. THE PHYSICIAN ATTEMPTED TO POSITION A 14MM OUTER DIAMETER (O.D.) X 40MM ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM ACROSS THE STRICTURE. HOWEVER, THE STENT DELIVERY SYSTEM WAS TOO THICK TO PASS THE STENOSIS. THE PHYSICIAN REPOSITIONED THE GUIDEWIRE INTO THE LOWER LOBE BRONCHUS. HOWEVER, THE PHYSICIAN WAS STILL UNABLE TO ADVANCE THE STENT SYSTEM ACROSS THE STRICTURE. THE PHYSICIAN DID NOT ALLEGE A COMPLAINT AGAINST THIS DEVICE. THE PHYSICIAN STATED THAT HE CHOSE THE WRONG SIZE STENT SYSTEM FOR THE PATIENT ANATOMY. THE PHYSICIAN THEN POSITIONED A 14MM O.D. X 30MM ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM (THE SUBJECT OF MFR. REPORT # 3005099803-2011-02206) ACROSS THE STRICTURE. THE PHYSICIAN BEGAN DEPLOYMENT OF THE STENT. HOWEVER, WHEN THE STENT WAS APPROXIMATELY HALF-WAY DEPLOYED, THE DEPLOYMENT SUTURE BROKE. THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT. THE PHYSICIAN THEN POSITIONED A 12MM O.D. X 30MM ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM (THE SUBJECT OF MFR. REPORT # 3005099803-2011-02207) ACROSS THE STRICTURE. THE STENT WAS DEPLOYED. THE PHYSICIAN MADE A MINOR ADJUSTMENT OF THE STENT POSITION USING FORCEPS. THE PHYSICIAN WAS CONTENT WITH THE LOCATION OF THE STENT PLACEMENT. HOWEVER, WHEN CHECKING THE STENT, A FOREIGN BODY WAS DETECTED NEAR THE DISTAL END OF THE STENT. THE FOREIGN BODY WAS RETRIEVED FROM THE PATIENT USING BIOPSY FORCEPS. IT WAS DISCOVERED THAT THE FOREIGN BODY WAS A CLEAR RUBBER RING FROM THE STENT DELIVERY CATHETER OF THE THIRD STENT SYSTEM. THE PHYSICIAN CONFIRMED THAT NO OTHER COMPONENTS OF THE STENT DELIVERY SYSTEM WERE LEFT INSIDE OF THE PATIENT. THE STENT WAS LEFT IMPLANTED IN THE DESIRED POSITION. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "STABLE."

    Description of Event or Problem · 1

    NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 3005099803-2011-02206). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEMS WERE USED DURING A STENT PLACEMENT PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD NON-SMALL-CELL CARCINOMA WITH TUMOR INVASION INTO THE LEFT MAINSTEM BRONCHUS. THE STRICTURE WAS APPROXIMATELY 3CM IN LENGTH. THE ANATOMY WAS NOTED TO BE TORTUOUS; HOWEVER, THE STRICTURE WAS NOT DILATED PRIOR TO STENT PLACEMENT. THE PHYSICIAN ATTEMPTED A STIFF INTUBATION BUT WAS UNSUCCESSFUL DUE TO ANATOMIC CONDITIONS. INTUBATION WAS ACHIEVED USING A 8.0 RÖSCH TUBE. AN AMPLATZ GUIDEWIRE WAS INSERTED INTO THE LEFT UPPER LOBE. THE PHYSICIAN ATTEMPTED TO POSITION A 14MM OUTER DIAMETER (O.D.) X 40MM ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM ACROSS THE STRICTURE. HOWEVER, THE STENT DELIVERY SYSTEM WAS TOO THICK TO PASS THE STENOSIS. THE PHYSICIAN REPOSITIONED THE GUIDEWIRE INTO THE LOWER LOBE BRONCHUS. HOWEVER, THE PHYSICIAN WAS STILL UNABLE TO ADVANCE THE STENT SYSTEM ACROSS THE STRICTURE. THE PHYSICIAN DID NOT ALLEGE A COMPLAINT AGAINST THIS DEVICE. THE PHYSICIAN STATED THAT HE CHOSE THE WRONG SIZE STENT SYSTEM FOR THE PATIENT ANATOMY. THE PHYSICIAN THEN POSITIONED A 14MM O.D. X 30MM ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM (THE SUBJECT OF MFR. REPORT # 3005099803-2011-02206) ACROSS THE STRICTURE. THE PHYSICIAN BEGAN DEPLOYMENT OF THE STENT. HOWEVER, WHEN THE STENT WAS APPROXIMATELY HALF-WAY DEPLOYED, THE DEPLOYMENT SUTURE BROKE. THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT. THE PHYSICIAN THEN POSITIONED A 12MM O.D. X 30MM ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM (THE SUBJECT OF MFR. REPORT # 3005099803-2011-02207) ACROSS THE STRICTURE. THE STENT WAS DEPLOYED. THE PHYSICIAN MADE A MINOR ADJUSTMENT OF THE STENT POSITION USING FORCEPS. THE PHYSICIAN WAS CONTENT WITH THE LOCATION OF THE STENT PLACEMENT. HOWEVER, WHEN CHECKING THE STENT, A FOREIGN BODY WAS DETECTED NEAR THE DISTAL END OF THE STENT. THE FOREIGN BODY WAS RETRIEVED FROM THE PATIENT USING BIOPSY FORCEPS. IT WAS DISCOVERED THAT THE FOREIGN BODY WAS A CLEAR RUBBER RING FROM THE STENT DELIVERY CATHETER OF THE THIRD STENT SYSTEM. THE PHYSICIAN CONFIRMED THAT NO OTHER COMPONENTS OF THE STENT DELIVERY SYSTEM WERE LEFT INSIDE OF THE PATIENT. THE STENT WAS LEFT IMPLANTED IN THE DESIRED POSITION. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAF PROSTHESIS, TRACHEAL, EXPANDABLE JCT BOSTON SCIENTIFIC - GALWAY M00564770 0014088572

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention