MAUDE Adverse Event Report: ABIOMED, INC. IMPELLA 5.5; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Model Number	IMPELLA 5.5
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/10/2022
Type of Reportable Event	Death
Event or Problem Description
The complainant reported a patient in acute myocardial infarction/cardiogenic shock was implanted with an impella cp device for mechanical circulatory support.The patient was then escalated from the impella cp to an impella 5.5 for increased circulatory support after 4 days of support on the impella cp.When the patient was brought to the operating room (or) to replace the impella cp with impella 5.5 the decision was made for the patient to have coronary artery bypass (cabg).The patient was placed on bypass, and the impella was place directly through the aorta after an aortic valve replacement was performed.Cabg was performed successfully and without complications.The impella 5.5 placement was confirmed with transesophageal echocardiography (tee), support was initiated and the patient was weaned off bypass.Tee of the right ventricle revealed worsening right heart function.The patient was given an increased inotrope support and transported back to the icu.The following day, on (b)(6) 2022, the patient was taken back to the or for venoarterial extracorporeal membrane oxygenation cannulation (va ecmo) due to the failing right ventricle and associated decompensation.During this time, it was reported that the impella 5.5 had alarms for high purge pressure.The medical team decided to place tissue plasminogen activator in the purge solution.The high purge pressure alarm was resolved; however, it was noted that the pressure remained high, with the mean motor current within expected ranges.There were no further impella complications and the patient was transported back to the icu.On (b)(6) 2022, the patient's right lung was discovered to be necrotic.The surgical team made plans for resection at a later time, however the patient continued to decline and required increased support despite the patient being supported by impella 5.5, va ecmo, and hemodialysis.The family made the decision to withdraw care, and the patient expired.Although the patient's presenting condition may be more likely have impacted the event the impella cannot be excluded as a possible contributing factor due to the high purge pressure which is a product malfunction and cannot exclude this from the outcome of demised.
Additional Manufacturer Narrative
The impella device was not received from the customer, therefore, investigation of the device was not possible.Should the device or any new information be received, a supplemental mdr will be filed.Impella 5.5 with smartassist for use during cardiogenic shock and high-risk pci instructions for use for the related event are as follows: section: potential adverse events (united states) ¿acute renal dysfunction, aortic valve injury, bleeding, cardiogenic shock, cerebral vascular accident/stroke, death, hemolysis, limb ischemia, myocardial infarction, renal failure, thrombocytopenia and cardiac or vascular injury (including ventricular perforation).¿ section: using the automated impella controller with the impella catheter ¿unresolved purge pressure high alarm if not resolved by the recommendations provided, high purge pressure¿which triggers the ¿purge pressure high¿ alarm message¿could be an indication of a kink in the impella catheter.In this case, the motor is no longer being purged and may eventually stop.Clinicians should monitor motor current and consider replacing the impella catheter whenever a rise in motor current is seen.¿ this report is being filed as part of a retrospective review of historical records.

• Brand Name: IMPELLA 5.5
• Common Device Name: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED, INC.; 22 cherry hill dr.; danvers MA 01923
• Manufacturer (Section G): ABIOMED, INC.; 22 cherry hill dr.; danvers MA 01923
• Manufacturer Contact: derek sammarco
• MDR Report Key: 21732344
• Report Number: 1220648-2025-27106
• Device Sequence Number: 11757575
• Product Code: OZD
• UDI-Device Identifier: 00813502011531
• UDI-Public: (01)00813502011531(10)2023255173(17)240731
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: 140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/31/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: IMPELLA 5.5
• Device Catalogue Number: 0550-0008
• Device Lot Number: 2023255173
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2022
• Initial Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: White