BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERA PERIPHERAL STENT SYSTEM

    MDR report key: 9089831 · Received September 19, 2019

    Report

    Report Number
    2024168-2019-11932
    Event Type
    Malfunction
    Date Received
    September 19, 2019
    Date of Event
    August 30, 2019
    Report Date
    December 16, 2019
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIP
    PMA / PMN Number
    P120020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORDS IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOTS THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER SIMILAR INCIDENTS AND/OR COMPLAINTS FROM THE REPORTED LOTS. IN THIS CASE, IT IS LIKELY THAT THE PRODUCTS WERE MIXED AT THE HOSPITAL. IT IS LIKELY THAT THE CHIPBOARD BOXES OF THE TWO PRODUCTS WERE OPENED AT SOME POINT AND THE POUCH FOR SE-05-060-120 -6F WAS INADVERTENTLY PLACED BACK INTO THE CHIPBOARD BOX FROM PRODUCT 42055150-120 AND PLACED BACK INTO INVENTORY. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. CASE DETAILS: THE SIZE OF THE SUPERA WAS UPDATED FROM 5X150 TO 5.5X150. THE DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 0

    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.THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING UNPACKAGING OF THE SUPERA SELF-EXPANDING STENT SYSTEM, THE LABELING ON THE CHIPBOARD BOX DID NOT MATCH THE LABELING ON THE POUCH. THE CHIPBOARD BOX WAS LABELED AS 5.5X150MM SUPERA: PART NUMBER 42055150-120, LOT NUMBER 9043061. THE POUCH WAS LABELED AS 5X60MM SUPERA: PART NUMBER SE-05-060-120 -6F, LOT NUMBER 8031261. THE INNER POUCH WAS NOT OPENED. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING UNPACKAGING OF THE SUPERA SELF-EXPANDING STENT SYSTEM, THE LABELING ON THE CHIPBOARD BOX DID NOT MATCH THE LABELING ON THE POUCH. THE CHIPBOARD BOX WAS LABELED AS 5X150MM SUPERA: PART NUMBER 42055150-120, LOT NUMBER 9043061. THE POUCH WAS LABELED AS 5X60MM SUPERA: PART NUMBER SE-05-060-120 -6F, LOT NUMBER 8031261. THE INNER POUCH WAS NOT OPENED. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882657 SUPERA PERIPHERAL STENT SYSTEM SELF EXPANDING PERIPHERAL STENT SYSTEM NIP ABBOTT VASCULAR 9043061

    Patients

    Seq Age Sex Outcome Treatment
    1