BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERCROSS 035

    MDR report key: 12532082 · Received September 27, 2021

    Report

    Report Number
    2183870-2021-00354
    Event Type
    Injury
    Date Received
    September 27, 2021
    Date of Event
    September 22, 2021
    Report Date
    November 9, 2021
    Manufacturer
    COVIDIEN
    Product Code
    LIT
    UDI-DI
    00763000184513
    PMA / PMN Number
    K082579
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IMAGE REVIEW: THE CUSTOMER RETURNED ONE IMAGE. THE IMAGE SHOWS THE PATIENT VASCULATURE. THERE IS A DEPLOYED STENT AND A GUIDEWIRE VISIBLE. PRODUCT ANALYSIS: THE DEVICE RETURNED IN TWO-PIECES INSIDE A BIOHAZARD BAG INSIDE A SHELF CARTON INSIDE 2 BIOHAZARD BAGS. LOT NUMBER ON SHELF CARTON LABEL: A863540. THE DEVICE WAS DECONTAMINATED WITH CIDEX OPA SOLUTION SOAK AND TERGAZYME SOAK. THE DEVICE WAS RETURNED WITH THE BALLOON DETACHED DISTAL TO THE BALLOON BOND AND THE INNER DETACHED AT THE PROXIMAL MARKERBAND. THE PROXIMAL MARKER BAND IS PRESENT. A VISUAL INSPECTION OF THE DETACHED PORTION OF THE INNER SHAFT FOUND THAT THE DISTAL MARKERBAND WAS MISSING. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PHYSICIAN ATTEMPTED TO USE AN EVERCROSS PTA BALLOON WITH A 6FR NON-MEDTRONIC SHEATH AND A .035 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A SEVERE CALCIFIED LESION IN THE PATIENT¿S MID RIGHT PROXIMAL COMMON ILLIAC ARTERY. SLIGHT VESSEL TORTUOSITY IS REPORTED. LESION EXHIBITED CTO (CHRONIC TOTAL OCCLUSION-100%) STENOSIS. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. CONTRAST/ SALINE INFLATION FLUID WAS USED. NO EMBOLIC PROTECTION WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE AND NO EXCESSIVE FORCE WAS USED. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT THE BALLOON RUPTURED AND SHEARED IN HALF JUST DISTAL TO THE PROXIMAL MARKER WHEN INFLATED TO 10 ATMS. IT IS UNKNOWN WHERE THE BURST OCCURRED. 2 PRIOR INFLATIONS HAD BEEN APPLIED IN THE VESSEL AND THE RUPTURE OCCURRED DURING POST DILATION OF THE STENT. THE BALLOON FRAGMENTED. NO RESISTANCE WAS NOTED WHEN REMOVING THE DEVICE FROM THE PATIENT. THE FRAGMENTED B ALLOON PORTION WAS LEFT IN THE PATIENT. NO DAMAGE WAS NOTED TO THE VESSEL. AN ATTEMPT TO SNARE THE BALLOON PORTION WAS MADE BUT WAS UNSUCCESSFUL. ANOTHER STENT WHICH WAS NEEDED ANYWAYS WAS USED TO TRAP BALLOON PORTION AGAINST VESSEL WALL TO LET IT ENDOTHELIALIZE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1431692 EVERCROSS 035 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA LIT COVIDIEN AB35W06200135 A863540 00763000184513

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention