BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABIOMED 14F INTRODUCER KIT FOR IMPELLA

    MDR report key: 7026390 · Received November 13, 2017

    Report

    Report Number
    1035166-2017-00098
    Event Type
    Death
    Date Received
    November 13, 2017
    Date of Event
    November 1, 2017
    Report Date
    June 7, 2018
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    UDI-DI
    00813502010664
    PMA / PMN Number
    K122084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF DEVICE HISTORY RECORD (DHR) WAS CONDUCTED AND THERE WERE NO MANUFACTURING REJECTS OR ANOMALIES RECORDED IN THE DHR AFFECTING RELEASED PRODUCT. THE RELEASED DEVICE PASSED ALL IN-PROCESS AND QA FINAL INSPECTION STEPS INCLUDING VISUAL, DIMENSIONAL AND MECHANICAL TESTING BEFORE SHIPPING TO THE CUSTOMER. A COMPLAINT REVIEW OF THE REPORTED LOT FOUND NO ADDITIONAL REPORTS INVOLVING THIS LOT NUMBER. THE DEVICE WAS IN USE FOR TREATMENT. THE DEVICE IS NOT AVAILABLE FOR RETURN TO OSCOR FOR FURTHER ANALYSIS AND THERE WAS NO ALLEGATION BROUGHT AGAINST THE DEVICE REPORTED. NO INVESTIGATION WAS PERFORMED IN THIS CASE AS THE EVENT DID NOT INVOLVE A REPORTED FAILURE. NO FURTHER FOLLOW-UP IS REQUIRED. THE CLINICAL TEAM DID NOT ATTRIBUTE THE DEATH TO THE DEVICE OR ANY DEVICE FAILURE. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. OSCOR WILL CONTINUE TO MONITOR THIS EVENT TYPE."

    Additional Manufacturer Narrative · 1

    CONCLUSION NOT YET AVAILABLE, EVALUATION IN PROCESS. THIS INITIAL MDR IS BEING SUBMITTED TO MEET OUR REQUIREMENTS OF REPORTING. A FOLLOW-UP WILL BE SUBMITTED AS SOON AS THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT INCLUDED: THE ROOT CAUSE OF THE BLEED WAS NEVER DETERMINED. THE PHYSICIANS INDICATED THAT THE "PATIENT HAD A RETROPERITONEAL BLEED AT IMPELLA SITE AND WAS NOT OVERTLY BLEEDING OUT FROM SITE. THEY ALSO REPORTED REGARDING THE EVENT AND PATIENT DEATH: "MIGHT BE FROM THE SERIAL DILATIONS AND BELIEVES IT MAY HAVE BEEN FROM THE VESSEL AND LACK OF RECOIL AROUND ARTERIOTOMY." THE REPORTER ALSO STATED THAT THERE WAS NO SPECIFIC DEVICE FAILURE NOTED. REPORTER WAS ABLE TO CONFIRM THAT THE DEVICE IN QUESTION IS NOT AVAILABLE FOR RETURN AND ANALYSIS. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION SPECIFIC TO EXACT CAUSE AND DETAILS SURROUNDING THE DEATH OF THE PATIENT IS STILL UNKNOWN AT TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, TODAY I RECEIVED DETAILS OF AN ADVERSE EVENT REGARDING THE COMBO KIT OSCOR INTRODUCER PACKAGED WITH THE IMPELLA CP: 1. WHAT IS THE DATE OF EVENT? (B)(6) 2017. 2. WHAT IS THE NAME OF THE FACILITY WHERE EVENT OCCURRED? (B)(6). 3. WHAT IS THE OUTCOME OF THE PATIENT? (E.G. PATIENT STABLE, PATIENT ALIVE, NO INJURY, SERIOUS INJURY, DEATH) DEATH. 4. WHAT PROCEDURE WAS THE PRODUCT USED FOR? A HIGH RISK PCI, ACCESS FOR INSERTION OF THE IMPELLA CP. 5. WHAT WAS THE CONDITION OF THE PATIENT WHEN PRESENTED TO THE PHYSICIAN? THE PATIENT WAS A 46YO FEMALE PRESENTED WITH NSTEMI, HISTORY OF CABG AND AAA REPAIR. 6. WAS THERE AN ISSUE WITH THE PRODUCT ? IF YES , THEN PROVIDE DETAILS OF THE ISSUE AND ANSWER THE QUESTIONS A) AND B). YES. A. WHEN WAS THE ISSUE IDENTIFIED? (BEFORE , DURING OR AFTER THE PROCEDURE) POST PROCEDURE. B. WHAT WAS THE USER (PHYSICIAN/ DOCTOR/ NURSE) DOING WHEN THE ISSUE OCCURRED? THE IMPELLA CP WAS EXPLANTED AND PATIENT WAS IN HOSPITAL WHEN THE RETROPERITONEAL BLEED WAS DISCOVERED. 7. PLEASE PROVIDE THE CONTACT INFORMATION OF THE PHYSICIAN WHO USED THE PRODUCT TO OBTAIN ADDITIONAL CLINICAL INFORMATION OF THE EVENT IN QUESTION. N/A. 8. WHAT IS THE MODEL NUMBER AND LOT NO. OF THE DEVICE USED? OSCOR INTRODUCER C1-13589. 9. WAS THERE ANY ADDITIONAL DEVICES USED DURING THE PROCEDURE? N/A. 10. WHAT IS THE NAME, MODEL NO. AND LOT NO. FOR ANY ADDITIONAL DEVICE USED DURING THE PROCEDURE? N/A. 11. IN WHICH SEQUENCE THE DEVICES WERE USED IF MULTIPLE DEVICES WERE INVOLVED? SERIAL DILATIONS WERE DONE FOR 14X13 OSCOR INSERTION. PEELED AWAY, AND THEN THE IMPELLA CP WAS PLACED. THE BLEED WAS DISCOVERED POST PROCEDURE. VASCULAR REPAIR WAS PERFORMED AND 2-3 UNITS OF BLOOD WERE GIVEN. THE PATIENT DID EXPIRE. 12. ARE THE DEVICES AVAILABLE TO RETURN TO OSCOR FOR EVALUATION? THE FIELD REP HAS BEEN UNABLE TO LOCATE ANY OF THE DISSPOSABLE PRODUCT TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805882 ABIOMED 14F INTRODUCER KIT FOR IMPELLA INTRODUCER, CATHETER DYB OSCOR INC. 0052-3025 C1-13589 00813502010664

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death IMPELLA CP