BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

    MDR report key: 6187863 · Received December 19, 2016

    Report

    Report Number
    2024168-2016-09028
    Event Type
    Death
    Date Received
    December 19, 2016
    Date of Event
    September 24, 2016
    Report Date
    December 29, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    PNY
    UDI-DI
    08717648157042
    PMA / PMN Number
    P150023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF THROMBOSIS, CARDIAC ARREST AND DEATH, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE (IFU), ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. BASED ON THE CASE INFORMATION, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE LOT HISTORY RECORD WAS PERFORMED AND REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INDEX PROCEDURE ON (B)(6) 2016 WAS TO TREAT SEVERAL LESIONS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY, IN THE FIRST AND SECOND MARGINAL BRANCH, IN THE PROXIMAL PORTION OF THE CIRCUMFLEX AND MID PORTION OF THE RIGHT CORONARY ARTERY. A TOTAL OF 5 ABSORB WERE IMPLANTED WITH A 3.0X28MM ABSORB IMPLANTED IN THE LAD. THE VESSEL WAS DETERMINED TO BE GREATER THAN 2.5MM IN DIAMETER. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. THE PATIENT WAS PRESCRIBED DUAL ANTI-PLATELET THERAPY (DAPT) AND WAS TAKING PRASUGREL. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2016. THIRTY MINUTES AFTER THE PATIENT ARRIVED AT THEIR HOME, THEY LOST CONSCIOUSNESS AND WAS SENT TO THE HOSPITAL AGAIN PRESENTING WITH RESPIRATORY CARDIOPULMONARY ARREST. IN-SCAFFOLD THROMBOSIS WAS IDENTIFIED IN THE 3.0X28MM ABSORB IMPLANTED IN THE LAD. ALL OTHER ABSORB SCAFFOLDS WERE PATENT. THE PATIENT DIED ON (B)(6) 2016. THE PATIENT WAS CONFIRMED TO HAVE BEEN COMPLIANT WITH THEIR DAPT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835452 ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM BIORESORBABLE DRUG ELUTING SCAFFOLD PNY AV-TEMECULA-CT 5113061 08717648157042

    Patients

    Seq Age Sex Outcome Treatment
    1 Death OTHER: 4 ABSORB SCAFFOLDS