BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM

    MDR report key: 3090832 · Received May 2, 2013

    Report

    Report Number
    2024168-2013-02736
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIO
    PMA / PMN Number
    P110028
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4) - INDICATION FOR USE/NO PRE-DILATATION. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THE ABSOLUTE PRO VASCULAR SELF EXPANDING STENT SYSTEM INSTRUCTIONS FOR USE (IFU) STATES: THE ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH DE NOVO OR RESTENOTIC ATHEROSCLEROTIC LESIONS IN THE NATIVE COMMON ILIAC ARTERY AND NATIVE EXTERNAL ILIAC ARTERY. ADDITIONALLY, THE IFU STATES: LESION/VESSELS SHOULD BE PRE-DILATED USING STANDARD PTA TECHNIQUE. PRE-DILATATION BALLOON DIAMETER SHOULD CLOSELY MATCH THE LUMEN DIAMETER PROXIMAL AND DISTAL TO THE LESION TO BE TREATED. WITHDRAW THE BALLOON DILATATION CATHETER WHILE LEAVING THE GUIDE WIRE IN PLACE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THAT DURING THE PROCEDURE IN THE COMMON ILIAC ARTERY FOR TREATMENT OF A PRE-EXISTING UNSPECIFIED STENT, THE DECISION WAS MADE TO IMPLANT A 8.0X60X135 ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT INSIDE OF THE PRE-EXISTING STENT AS THE STENT WAS "GROSSLY UNDERSIZED" (THE STENT SIZE SELECTED DURING INITIAL IMPLANT WAS TOO SMALL). ATHERECTOMY WAS PERFORMED AND THE ABSOLUTE PRO VASCULAR STENT DELIVERY SYSTEM WAS ADVANCED INTO THE PREVIOUSLY IMPLANTED STENT WITHOUT RESISTANCE. DURING STENT DEPLOYMENT, SIGNIFICANT RESISTANCE WAS FELT. AS THE SELF-EXPANDING STENT HAD ALREADY STARTED TO DEPLOY, IT WAS NECESSARY FOR THE PHYSICIAN TO CONTINUE WITH DEPLOYMENT OF THE STENT. ONCE THE STENT HAD FULLY DEPLOYED, IT JUMPED FROM INSIDE THE PREVIOUSLY IMPLANTED STENT INTO THE AORTA. A VASCULAR SURGEON CONFIRMED THAT THE ABSOLUTE PRO STENT WAS APPOSED IN THE AORTA AND THE PROCEDURE WAS STOPPED. ALTHOUGH THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE, THERE WAS NO ADVERSE PATIENT SEQUELA AND THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192369 ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM NIO AV-TEMECULA-CT 1120161

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other