BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

    MDR report key: 6396378 · Received March 10, 2017

    Report

    Report Number
    2024168-2017-02011
    Event Type
    Injury
    Date Received
    March 10, 2017
    Date of Event
    August 10, 2016
    Report Date
    March 17, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    PNY
    PMA / PMN Number
    P150023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 SCAFFOLD REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE ABSORB DEVICE IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE US.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED AS THE SCAFFOLD REMAINS IN THE ANATOMY. 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 ANGINA AND RESTENOSIS, AS LISTED IN THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM, ABSORB, INSTRUCTIONS FOR USE ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH THE USE OF A CORONARY SCAFFOLD IN NATIVE CORONARY ARTERIES. 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 AND THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2014, THE PATIENT UNDERWENT A CORONARY PROCEDURE, WITH IMPLANTATION OF A 3.5 X 28 MM ABSORB BIORESORBABLE VASCULAR SCAFFOLD (BVS) IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. IN (B)(6) 2016, THE PATIENT BEGAN TO EXPERIENCE CHEST PAIN AND WAS RE-HOSPITALIZED. A REVASCULARIZATION PROCEDURE WAS PERFORMED AT THE TARGET LESION, WITH STENT IMPLANTATION, AND THE PATIENT CONDITION RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL 30-DAY MEDICAL DEVICE REPORT, ADDITIONAL INFORMATION WAS RECEIVED, INDICATING THAT ON (B)(6) 2016, 80% STENOSIS WAS NOTED WITHIN 5 MM OF THE IMPLANTED ABSORB SCAFFOLD. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176578 ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM BIORESORBABLE DRUG ELUTING SCAFFOLD PNY AV-TEMECULA-CT 31001PB

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R