BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

    MDR report key: 6171948 · Received December 13, 2016

    Report

    Report Number
    2024168-2016-08834
    Event Type
    Injury
    Date Received
    December 13, 2016
    Date of Event
    November 28, 2016
    Report Date
    December 13, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    PNY
    UDI-DI
    08717648157028
    PMA / PMN Number
    P150023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION AND THROMBOSIS, 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 AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIRST PROCEDURE ON (B)(6) 2015 WAS TO TREAT A PATIENT WITH A MYOCARDIAL INFARCTION (MI). A DRUG ELUTING STENT WAS IMPLANTED IN THE RIGHT CORONARY ARTERY. THE FOLLOWING DAY AN ARTERIAL VENOUS FISTULA IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WAS TREATED WITH STAINLESS STEEL COILS. THEN A LESION ON THE FISTULA IN THE PROXIMAL LAD WAS TREATED. PRE-DILATATION WAS DONE WITH A 2.5 X 15 MM BALLOON, REDUCING THE STENOSIS TO 0%. THE 3.0 X 18 MM ABSORB SCAFFOLD WAS IMPLANTED AND POST-DILATED TWICE WITH A 3.0 NON-COMPLIANT (NC) BALLOON AT 20 ATMOPSHERES. THE PATIENT WAS RELEASED ON DUAL ANTIPLATELET DRUG THERAPY FOR 12 MONTHS. ON (B)(6) 2016, THE PATIENT RETURNED WITH A MI AND SCAFFOLD THROMBOSIS WAS FOUND. THE THROMBOSIS WAS ASPIRATED AND PRE-DILATED WITH AN NC BALLOON. A 3.0 X 23 MM XIENCE STENT WAS IMPLANTED AND POST-DILATED WITH A 3.0 X 15 MM BALLOON. THE PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820650 ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM BIORESORBABLE DRUG ELUTING SCAFFOLD PNY AV-TEMECULA-CT 412176A 08717648157028

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S