BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

    MDR report key: 2874400 · Received December 14, 2012

    Report

    Report Number
    2024168-2012-07968
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 21, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED INFLATION ISSUE COULD NOT BE REPLICATED AS THE RETURNED DEVICE WAS NOT RETURNED IN A CONDITION IN WHICH THE TEST COULD BE PERFORMED. THE REPORTED DIFFICULTY REMOVING THE PROTECTIVE SHEATH COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS THE PROTECTIVE SHEATHS WERE NOT RETURNED. BASED ON THE VISUAL AND DIMENSIONAL ANALYSIS OF THE DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE HAS BEEN RETURNED FOR INVESTIGATION. THE INVESTIGATION IS NOT COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. DATE OF EVENT - ESTIMATED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CALCIFIED LESION (VESSEL UNKNOWN). THE NURSE THAT WAS PREPARING THE DEVICE INDICATED THAT RESISTANCE WAS NOTED WHEN REMOVING THE PLASTIC COVER OF THE BIORESORBABLE VASCULAR SCAFFOLD (BVS) DURING THE PREPARATION, OUTSIDE THE PATIENT. THE LESION WAS PREDILATED WITH 2 BALLOON CATHETERS. THE BVS WAS ADVANCED WITHOUT RESISTANCE AND WAS POSITIONED. PRESSURE WAS APPLIED FIRST TO 2 ATMOSPHERES (ATM) AND THEN TO 4 ATM AND THEN HIGHER BUT THE BALLOON DID NOT INFLATE. THE BVS WAS REMOVED FROM THE PATIENT'S ANATOMY WITHOUT FRICTION OR RESISTANCE. THE PROCEDURE WAS FINISHED BY IMPLANTING A NON-ABBOTT STENT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2071761

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR GUIDE WIRE: PT GRAPHIC