BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSOLUTE PRO VASCULAR

    MDR report key: 8886119 · Received August 12, 2019

    Report

    Report Number
    2024168-2019-10793
    Event Type
    Injury
    Date Received
    August 12, 2019
    Date of Event
    July 13, 2019
    Report Date
    October 30, 2019
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIP
    UDI-DI
    08717648176173
    PMA / PMN Number
    P110028
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER INCIDENTS. THE INVESTIGATION DETERMINED THAT THE REPORTED DIFFICULTIES AND SUBSEQUENT TREATMENT APPEAR TO BE DUE TO OPERATIONAL CONTEXT OF THE PROCEDURE. IT IS LIKELY THAT THE CLEARANCE BETWEEN THE INNER DIAMETER OF THE SHEATH AND THE ABSOLUTE PRO SELF EXPANDING STENT SYSTEM (SESS) SHAFT WAS REDUCED, LIKELY DUE TO KINK OR ANATOMICAL CONDITIONS, AND AS A RESULT, THE STENT WAS UNSHEATHED RESULTING IN DEPLOYMENT. ADDITIONALLY, THE DIFFICULTY REMOVING, AND STENT SEPARATION WAS THE RESULT OF PULLING THE SESS BACK INTO THE INTRODUCER SHEATH WITH THE STENT PARTIALLY EXPANDED AGAINST THE VESSEL WALL. THE ABSOLUTE PRO INSTRUCTION FOR USE (IFU) WARNS: SHOULD UNUSUAL RESISTANCE BE FELT AT ANY TIME DURING LESION OR STRICTURE ACCESS OR DELIVERY SYSTEM REMOVAL, THE INTRODUCER SHEATH / GUIDING CATHETER AND STENT SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT. APPLYING EXCESSIVE FORCE TO THE STENT DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND DELIVERY SYSTEM COMPONENTS. IN THIS CASE, THE RESISTANCE WAS RELATED TO PROCEDURAL CIRCUMSTANCES AND THE FORCE REQUIRED TO REMOVE THE DELIVERY SYSTEM WAS REQUIRED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. EXEMPTION NUMBER E2019001-PERMITS NUMBERING SEQUENCE TO BEGIN WITH 10000, TO AVOID DUPLICATION OF REPORT NUMBERS DUE TO PROCESS TRANSITION. THERE MAY BE GAPS IN NUMBERING FOR REPORTS SUBMITTED DURING THE TRANSITION PERIOD.

    Additional Manufacturer Narrative · 0

    G9: EXEMPTION NUMBER E2019001-PERMITS NUMBERING SEQUENCE TO BEGIN WITH 10000, TO AVOID DUPLICATION OF REPORT NUMBERS DUE TO PROCESS TRANSITION. THERE MAY BE GAPS IN NUMBERING FOR REPORTS SUBMITTED DURING THE TRANSITION PERIOD. H6: DEVICE CODE 2017: EXCESSIVE FORCE. THE DEVICE IS NOT RETURNING. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT COMMON ILIAC ARTERY. AN 8X100MM ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (SESS) FELT RESISTANCE WITH A NON-ABBOTT 6F GUIDING SHEATH DURING ADVANCEMENT. THEN THE STENT SEPARATED INTO TWO PIECES. THE DELIVERY CATHETER FACED RESISTANCE WITH THE ANATOMY DURING REMOVAL, SO FORCE WAS APPLIED. THE SEPARATED PORTION WAS EMBEDDED INTO THE ARTERY WALL WITH AN UNSPECIFIED BALLOON. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678463 ABSOLUTE PRO VASCULAR SELF EXPANDING PERIPHERAL STENT SYSTEM NIP ABBOTT VASCULAR 9012461 08717648176173

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 6 F DESTINATION SHEATH