BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25330952 · Received May 29, 2026

    Report

    Report Number
    1220648-2026-08265
    Event Type
    Injury
    Date Received
    May 29, 2026
    Date of Event
    May 19, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5 UPDATED WITH ADDITIONAL INFORMATION RECEIVED FROM THE CLINICAL SITE. H6 MEDICAL DEVICE PROBLEM CODE A140505 ADDED BASED ON ADDITIONAL INFORMATION RECEIVED.

    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. RELATED MEDICAL DEVICE REPORTS: THIS IMPELLA CP DEVICE REPORT IS ONE OF TWO DEVICES ASSOCIATED WITH THE EVENT. REFER TO THE RELATED MANUFACTURER REPORT NUMBER AS NOTED IN SECTION H10 FOR THE MEDICAL DEVICE REPORT ON THE IMPELLA GUIDE WIRE 0.018" PTFE COATED.

    Description of Event or Problem · 0

    NO ISSUES WERE REPORTED DURING REMOVAL OF THE PRODUCT FROM ITS PACKAGING. THE PRODUCT WAS CAREFULLY LAID OUT BY THE TECHNICIAN AND INSPECTED DURING THE PRIMING PROCESS, WITH NO ISSUES IDENTIFIED. NO ISSUES WERE NOTED DURING ADVANCEMENT OVER THE GUIDEWIRE ON THE INITIAL INSERTION; THE ISSUE WAS ONLY ENCOUNTERED DURING REINSERTION. IT IS UNKNOWN WHETHER A NEW GUIDEWIRE WAS USED OR IF THE ORIGINAL GUIDEWIRE WAS RESHAPED OR MODIFIED. IT IS UNKNOWN WHETHER ANY UNUSUAL FORCE WAS APPLIED TO THE DEVICE. THE DEVICE WAS EASILY REMOVED PRIOR TO REINSERTION AND AGAIN AT THE TIME OF FINAL EXPLANT THE FOLLOWING DAY. A "BUZZING" SOUND WAS REPORTED, APPEARING TO ORIGINATE FROM THE MOTOR AREA OF THE PUMP, DESCRIBED AS SIMILAR TO AN OBJECT CONTACTING A CEILING FAN, BUT AT A HIGHER FREQUENCY. THE DEVICE WAS VISUALIZED AS SET AT P-0; HOWEVER, IT WAS NOTED THAT IT MAY BE INFERRED THAT IT MAY HAVE CONTINUED OPERATING AT A PRIOR PERFORMANCE LEVEL. ONCE THE IMPELLA DRIVELINE WAS DISCONNECTED FROM THE AIC AND THE AIC WAS RESTARTED, DEVICE OPERATION PROCEEDED WITHOUT FURTHER ISSUE.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA CP DEVICE WAS INSERTED VIA THE LEFT FEMORAL ARTERY IN A 55-YEAR-OLD MALE PATIENT FOR THE INDICATION OF AORTIC VALVULOPLASTY, WITH A PRE-SUPPORT CLINICAL CONDITION CONSISTENT WITH SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) STAGE A. FOLLOWING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, THE CLINICAL TEAM ELECTED TO SWITCH GROIN ACCESS TO MAINTAIN IMPELLA CP SUPPORT. THE DEVICE WAS INITIALLY POSITIONED VIA THE RIGHT FEMORAL ARTERY; HOWEVER, DUE TO EXCESSIVE BLEEDING FROM THE RIGHT GROIN SITE, THE DECISION WAS MADE TO REMOVE AND REINSERT THE IMPELLA CP VIA THE LEFT FEMORAL ARTERY. UPON REINSERTION, THE IMPELLA CP WAS OBSERVED TO BE OPERATING AT PERFORMANCE LEVEL P-0. ATTEMPTS TO ADVANCE THE ABIOMED 0.018-INCH GUIDEWIRE WERE UNSUCCESSFUL AND ASSOCIATED WITH ABNORMAL RESISTANCE DESCRIBED AS A "BUZZING" SENSATION. THE DEVICE WAS TEMPORARILY TURNED OFF AND SUBSEQUENTLY RESTARTED. FOLLOWING THIS, THE DEVICE WAS ADVANCED UNDER FLUOROSCOPIC GUIDANCE AND REACTIVATED. DURING SUPPORT, NO PLACEMENT SIGNAL WAS OBSERVED ON THE AUTOMATED IMPELLA CONTROLLER (AIC)DESPITE CONFIRMATION OF APPROPRIATE PUMP POSITIONING BY ECHOCARDIOGRAM. THE ABSENCE OF A PLACEMENT SIGNAL WAS CONSIDERED POTENTIALLY RELATED TO OPTICAL SENSOR DYSFUNCTION. PLACEMENT OF A NEW IMPELLA CP DEVICE WAS RECOMMENDED AS THE SAFEST COURSE OF ACTION; HOWEVER, THIS OPTION WAS DECLINED BY THE TREATING PHYSICIAN. DESPITE THE PLACEMENT SIGNAL ISSUE, THE IMPELLA CP REMAINED IN PLACE AND CONTINUED TO PROVIDE SUPPORT. THE PATIENT WAS SUCCESSFULLY WEANED FROM SUPPORT AND SURVIVED TO IMPELLA CP EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22143 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027869911 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1