BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAFILL10 3MM X 8CM

    MDR report key: 7309045 · Received March 2, 2018

    Report

    Report Number
    3008114965-2018-00547
    Event Type
    Malfunction
    Date Received
    March 2, 2018
    Date of Event
    February 9, 2018
    Report Date
    February 9, 2018
    Manufacturer
    REFER TO SECTION H10
    Product Code
    KRD
    UDI-DI
    10886704077046
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE USER DID NOT APPLY EXCESSIVE FORCE AT ANY TIME DURING THE PROCEDURE. THE EVENT DID NOT RESULT IN A PROCEDURAL DELAY. INITIAL REPORTER - PHONE: (B)(6). UPDATED COMPLAINT CONCLUSION: AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A STENT-ASSISTED COIL EMBOLIZATION OF A 10MM CORONARY ARTERY ANEURYSM, AFTER SIX COMPETITOR COILS WERE PLACED, THE 3MM X 8 CM DELTAFILL10 (DLF100308/S11154) THERMO-MECHANICAL COIL WAS SELECTED AS SEVENTH; HOWEVER, THERE WAS A COMPARTMENT AT THE NECK SIDE OF THE ANEURYSM (AT 3 O-CLOCK) AND IT WAS DECIDED THAT THE COIL SHAPE WAS NOT FIT FOR THE LESION AND COULD NOT BE PLACED IN THE ANEURYSM. THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE COIL WAS REPLACED WITH A COMPETITOR COIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUE OR DELAY. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. THE PATIENT¿S LEVEL OF VESSEL TORTUOSITY AND CALCIFICATION ARE REPORTEDLY UNKNOWN. A 0.014 190CM SION BLACK (ASAHI INTECC) GUIDEWIRE, A 7F 100CM HYPERION GUIDING CATHETER, A PROWLER SELECT LPES (606-S155FX/1773576) MICROCATHETER, AN ENPOWER (ECB000182-00/S13940) CONTROL CABLE, A 3.5 X 8 XIENCE XPEDITION (ABBOTT VASCULAR) STENT, AND SIX (6) IDC (BOSTON SCIENTIFIC) COILS WERE ALSO USED IN THE CASE. COIL EMBOLIZATION WAS INITIATED FOLLOWING STENT PLACEMENT. SIX IDC (BOSTON SCIENTIFIC) COILS WERE PLACED PRIOR TO THIS COIL. THE COMPLAINT COIL WAS SELECTED FOR USE AS FINISHING COIL. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIOR TO THE EVENT. THE USER DID NOT APPLY EXCESSIVE FORCE AT ANY TIME DURING THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. WITH THE LIMITED INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. THE EXACT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, CLINICAL AND PROCEDURAL FACTORS INCLUDING PATIENT ANATOMY AND DEVICE SELECTION, MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE/PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSICAL MANUFACTURER NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. (B)(4). CONCOMITANT MED PRODUCTS: SION BLACK 0.014 190 CM (ASAHI INTECC) GW, HYPERION 7FR 100CM GUIDING CATHETER, PROWLER SELECT LPES (606-S155FX/1773576) MC, ENPOWER (ECB000182-00/S13940) CC, XIENCE XPEDITION 3.5×8 (ABBOTT VASCULAR) STENT, (6) IDC (BOSTON SCIENTIFIC) COILS, DCB200050 DCB. PHYSICAL MANUFACTURER NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. (B)(4). COMPLAINT CONCLUSION: A REPORT WAS RECEIVED THAT DURING A STENT-ASSISTED COIL EMBOLIZATION OF A 10MM CORONARY ARTERY ANEURYSM, AFTER SIX COMPETITOR COILS WERE PLACED, THE 3MM X 8 CM DELTAFILL10 (DLF100308/S11154) THERMO-MECHANICAL COIL WAS SELECTED AS SEVENTH; HOWEVER, THERE WAS A COMPARTMENT AT THE NECK SIDE OF THE ANEURYSM (AT 3 O-CLOCK) AND IT WAS DECIDED THAT THE COIL SHAPE WAS NOT FIT FOR THE LESION AND COULD NOT BE PLACED IN THE ANEURYSM. THE COIL WAS REPLACED WITH A COMPETITOR COIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUE OR DELAY. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. THE PATIENT¿S LEVEL OF VESSEL TORTUOSITY AND CALCIFICATION ARE REPORTEDLY UNKNOWN. A 0.014 190CM SION BLACK (ASAHI INTECC) GUIDEWIRE, A 7F 100CM HYPERION GUIDING CATHETER, A PROWLER SELECT LPES (606-S155FX/1773576) MICROCATHETER, AN ENPOWER (ECB000182-00/S13940) CONTROL CABLE, AN 3.5 X 8 XIENCE XPEDITION (ABBOTT VASCULAR) STENT, AND SIX (6) IDC (BOSTON SCIENTIFIC) COILS WERE ALSO USED IN THE CASE. COIL EMBOLIZATION WAS INITIATED FOLLOWING STENT PLACEMENT. SIX IDC (BOSTON SCIENTIFIC) COILS WERE PLACED PRIOR TO THIS COIL. THE COMPLAINT COIL WAS SELECTED FOR USE AS FINISHING COIL. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIOR TO THE EVENT. NO FURTHER INFORMATION WAS PROVIDED. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. WITH THE INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED; HOWEVER, CLINICAL AND PROCEDURAL FACTORS INCLUDING PATIENT ANATOMY AND DEVICE SELECTION, MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE/PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THE COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING A STENT-ASSISTED COIL EMBOLIZATION OF A 10MM CORONARY ARTERY ANEURYSM, AFTER SIX COMPETITOR COILS WERE PLACED, THE 3MM X 8 CM DELTAFILL10 (DLF100308/S11154) THERMO-MECHANICAL COIL WAS SELECTED AS SEVENTH; HOWEVER, THERE WAS A COMPARTMENT AT THE NECK SIDE OF THE ANEURYSM (AT 3 O-CLOCK) AND IT WAS DECIDED THAT THE COIL SHAPE WAS NOT FIT FOR THE LESION AND COULD NOT BE PLACED IN THE ANEURYSM. THE COIL WAS REPLACED WITH A COMPETITOR COIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUE OR DELAY. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. THE PATIENT¿S LEVEL OF VESSEL TORTUOSITY AND CALCIFICATION ARE REPORTEDLY UNKNOWN. A 0.014 190CM SION BLACK (ASAHI INTECC) GUIDEWIRE, A 7F 100CM HYPERION GUIDING CATHETER, A PROWLER SELECT LPES (606-S155FX/1773576) MICROCATHETER, AN ENPOWER (ECB000182-00/S13940) CONTROL CABLE, AN 3.5 X 8 XIENCE XPEDITION (ABBOTT VASCULAR) STENT, AND SIX (6) IDC (BOSTON SCIENTIFIC) COILS WERE ALSO USED IN THE CASE. COIL EMBOLIZATION WAS INITIATED FOLLOWING STENT PLACEMENT. SIX IDC (BOSTON SCIENTIFIC) COILS WERE PLACED PRIOR TO THIS COIL. THE COMPLAINT COIL WAS SELECTED FOR USE AS FINISHING COIL. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIOR TO THE EVENT. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152703 DELTAFILL10 3MM X 8CM NEUROVASCULAR EMBOLIZATION DEVICE KRD REFER TO SECTION H10 S11154 10886704077046

    Patients

    Seq Age Sex Outcome Treatment
    1