BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT, 14FR INTRODUCER, 13CM&25CM, STERILE

    MDR report key: 24627590 · Received March 18, 2026

    Report

    Report Number
    1220648-2026-05557
    Event Type
    Injury
    Date Received
    March 18, 2026
    Date of Event
    March 10, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REMOVED SURGICAL INTERVENTION AND VESSEL PERFORATION FROM IP CODES. ALSO UPDATED IP PRODUCT STATUS NO DISPOSABLE PRODUCTS ARE AVAILABLE FOR RETURN. VASCULAR MD AND IC AGREED THE FIRST DEPLOYED PERCLOSE CAUSED THE HEMATOMA WITH THE PRESENT AORTO-ILIAC STENTS. NO PERFORATION. VASCULAR WAS ABLE TO CLOSE WITHOUT CUT DOWN.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ABIOMED INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ABIOMED INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    A 75 YEAR OLD FEMALE WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, WITH A PRE SUPPORT CLINICAL STATE CONSISTENT WITH SCAI STAGE E, UNDERWENT IMPELLA CP SUPPORT VIA RIGHT FEMORAL ARTERIAL ACCESS USING A PERCUTANEOUS APPROACH. THE PATIENT HAD SIGNIFICANT PRE EXISTING VASCULAR DISEASE, INCLUDING AORTO ILIAC STENTS, SEVERE PERIPHERAL ARTERIAL DISEASE, AND HEAVILY CALCIFIED FEMORAL AND ILIAC VESSELS. DURING THE PROCEDURE, A HEMATOMA DEVELOPED AT THE ACCESS SITE. THE INTERVENTIONAL CARDIOLOGIST ATTRIBUTED THE HEMATOMA TO THE INITIAL PERCLOSE CLOSURE DEVICE DEPLOYMENT RATHER THAN IMPELLA DEVICE FUNCTION. ON 04/09/2026, SITE FOLLOW UP CONFIRMED THAT BOTH THE VASCULAR PHYSICIAN AND INTERVENTIONAL CARDIOLOGIST AGREED THE FIRST DEPLOYED PERCLOSE DEVICE CAUSED THE HEMATOMA IN THE SETTING OF EXISTING AORTO ILIAC STENTS. THERE WAS NO EVIDENCE OF VESSEL PERFORATION, AND VASCULAR SURGERY WAS ABLE TO ACHIEVE CLOSURE WITHOUT SURGICAL CUTDOWN. THE PATIENT REMAINED STABLE FOLLOWING STENT REPAIR AND IMPELLA DEVICE EXPLANT ON 3/10/2026. THE DEVICE WILL NOT BE RETURNED; DEVICE INVOLVEMENT CANNOT BE FULLY ASSESSED WITHOUT PRODUCT EVALUATION AND DEVICE RETURN

    Description of Event or Problem · 0

    A 75 YEAR OLD FEMALE WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, WITH A PRE SUPPORT CLINICAL STATE CONSISTENT WITH SCAI STAGE E, UNDERWENT IMPELLA CP SUPPORT VIA RIGHT FEMORAL ARTERIAL ACCESS USING A PERCUTANEOUS APPROACH. THE PATIENT HAD SIGNIFICANT PRE EXISTING VASCULAR DISEASE, INCLUDING AORTOILIAC STENTS, SEVERE PERIPHERAL ARTERY DISEASE, AND HEAVILY CALCIFIED FEMORAL/ILIAC VESSELS. DURING THE CASE, A HEMATOMA DEVELOPED AT THE ACCESS SITE, WHICH THE INTERVENTIONAL CARDIOLOGIST ATTRIBUTED TO THE INITIAL PERCLOSE CLOSURE DEVICE RATHER THAN IMPELLA DEVICE FUNCTION. BASED ON THE INFORMATION PROVIDED, THE VASCULAR INJURY AND HEMATOMA WERE ATTRIBUTED TO PROCEDURAL FACTORS¿SPECIFICALLY THE INITIAL PERCLOSE DEPLOYMENT¿COMBINED WITH THE PATIENT¿S SEVERE UNDERLYING PERIPHERAL ARTERIAL DISEASE AND PRIOR VASCULAR STENTING. THERE WAS NO EVIDENCE THAT THE IMPELLA DEVICE MALFUNCTIONED OR CONTRIBUTED TO THE ACCESS SITE COMPLICATION. THE EVENT IS CONSISTENT WITH KNOWN PATIENT AND PROCEDURE RELATED RISKS IN COMPLEX VASCULAR ANATOMY. THE PATIENT REMAINED STABLE FOLLOWING STENT REPAIR AND DEVICE EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685971 KIT, 14FR INTRODUCER, 13CM&25CM, STERILE INTRODUCER, CATHETER (INTRODUCER) DYB ABIOMED, INC. - 1220648 S10010850

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention