BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE DILATATION CATHETER

    MDR report key: 23219465 · Received October 6, 2025

    Report

    Report Number
    2020394-2025-01612
    Event Type
    Injury
    Date Received
    October 6, 2025
    Date of Event
    September 24, 2019
    Report Date
    December 10, 2025
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    OZT
    PMA / PMN Number
    K150667
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: CHING YH, QU G, ARNAOUTAKIS GJ, WAYANGANKAR S, PENG YG. USE OF IMPELLA SUPPORT IN TRANSCATHETER AORTIC VALVE REPLACEMENT FOR A PATIENT WITH SEVERE AORTIC STENOSIS AND SIGNIFICANTLY REDUCED EJECTION FRACTION. J CARDIOTHORAC VASC ANESTH. 2020 MAR;34(3):744-746. DOI: 10.1053/J.JVCA.2019.09.025. MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUESTED AS THE LOT NUMBER REPORTED AS UNKNOWN. INVESTIGATION SUMMARY: THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. TWO FLUOROSCOPIC IMAGES WERE PROVIDED AND REVIEWED. FIG 1. PRE-DEPLOYMENT IMAGE WITH IMPELLA 2.5 IN POSITION ACROSS THE AORTIC VALVE. FIG 2. POST-DEPLOYMENT IMAGE WITH MEDTRONIC EVOLUT PRO IN PLACE. THEREFORE, BASED ON THE IMAGE THE REPORTED INJURY IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. LABELING REVIEW: AS THE REPORTED EVENT DID NOT INDICATE DEGRADATION OR LOSS OF EFFICACY, A RETAIN SAMPLE ANALYSIS IS NOT REQUIRED. G3, H6 (COMPONENT, METHOD). SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Additional Manufacturer Narrative · 0

    H11: CHING YH, QU G, ARNAOUTAKIS GJ, WAYANGANKAR S, PENG YG. USE OF IMPELLA SUPPORT IN TRANSCATHETER AORTIC VALVE REPLACEMENT FOR A PATIENT WITH SEVERE AORTIC STENOSIS AND SIGNIFICANTLY REDUCED EJECTION FRACTION. J CARDIOTHORAC VASC ANESTH. 2020 MAR;34(3):744-746. DOI: 10.1053/J.JVCA.2019.09.025. AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    IT WAS REPORTED IN THE JOURNAL NAMED "JOURNAL OF CARDIOTHORACIC AND VASCULAR ANESTHESIA" OF ARTICLE TITLED, "USE OF IMPELLA SUPPORT IN TRANSCATHETER AORTIC VALVE REPLACEMENT FOR A PATIENT WITH SEVERE AORTIC STENOSIS AND SIGNIFICANTLY REDUCED EJECTION FRACTION" THAT DURING IMPELLA DEVICE PLACEMENT AND AFTER POST-DILATATION BY USING BARD TRUE FLOW VALVULOPLASTY PERFUSION CATHETER, PATIENT BECAME HYPOTENSIVE, BRADYCARDIC AND EVENTUALLY WENT INTO PULSELESS ELECTRICAL ACTIVITY ARREST. IT WAS FURTHER REPORTED THAT CARDIOPULMONARY RESUSCITATION WAS INITIATED ALONG WITH TEMPORARY PACING, PLACEMENT OF A SUPRAGLOTTIC AIRWAY DEVICE, EPINEPHRINE INFUSION AND IMPELLA PUMP PLACEMENT, A RETURN OF SPONTANEOUS CIRCULATION WAS ACHIEVED AND THE PROCEDURE CONCLUDED UNEVENTFULLY. REPORTEDLY, THE PATIENT WAS RECOVERED WELL WITH PROGRESSIVE IMPROVEMENT IN HIS DAILY FUNCTION AND ACTIVITIES.

    Description of Event or Problem · 0

    IT WAS REPORTED IN THE JOURNAL NAMED "JOURNAL OF CARDIOTHORACIC AND VASCULAR ANESTHESIA" OF ARTICLE TITLED, "USE OF IMPELLA SUPPORT IN TRANSCATHETER AORTIC VALVE REPLACEMENT FOR A PATIENT WITH SEVERE AORTIC STENOSIS AND SIGNIFICANTLY REDUCED EJECTION FRACTION" THAT DURING IMPELLA DEVICE PLACEMENT AND AFTER POST-DILATATION BY USING BARD TRUE FLOW VALVULOPLASTY PERFUSION CATHETER, PATIENT BECAME HYPOTENSIVE, BRADYCARDIC AND EVENTUALLY WENT INTO PULSELESS ELECTRICAL ACTIVITY ARREST. IT WAS FURTHER REPORTED THAT CARDIOPULMONARY RESUSCITATION WAS INITIATED ALONG WITH TEMPORARY PACING, PLACEMENT OF A SUPRAGLOTTIC AIRWAY DEVICE, EPINEPHRINE INFUSION AND IMPELLA PUMP PLACEMENT, A RETURN OF SPONTANEOUS CIRCULATION WAS ACHIEVED AND THE PROCEDURE CONCLUDED UNEVENTFULLY. REPORTEDLY, THE PATIENT WAS RECOVERED WELL WITH PROGRESSIVE IMPROVEMENT IN HIS DAILY FUNCTION AND ACTIVITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1869054 TRUE DILATATION CATHETER BALLOON VALVULOPLASTY CATHETER OZT BARD PERIPHERAL VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention