MAUDE Adverse Event Report: ABIOMED, INC. IMPELLA 5.0; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Model Number	IMPELLA 5.0 AIC PUMP SET US
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Codes	Sepsis (2067); Tachycardia (2095)
Date of Event	08/21/2021
Type of Reportable Event	Death
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.This report is being filed as part of a retrospective review of historical records.
Event or Problem Description
The complainant reported a patient in acute myocardial infarction/cardiogenic shock was implanted with an impella 5.0 device for mechanical circulatory support.The patient had been admitted to the hospital for respiratory failure with ekg changes.The patient was initially implanted with an impella cp but was later then escalated to an impella 5.0.It was reported while on impella 5.0 support, the patient experienced episodes of ventricular tachycardia on (b)(6) 2021 that was resolved with defibrillation on two occasions.The patient also had sputum cultures that day that were positive for gram positive cocci and rods with an elevated white blood count of 15,000 cells/ul.The relationship of the infection to the impella is unlikely, however the cause of the infection was unknown or not reported.It was noted that there were no impella concerns.The patient was moved to the covid unit the same day, on (b)(6) 2021.It was reported the night on (b)(6) 2021 the pump had alarms for high purge pressure and low purge flow.The medical team performed the tissue plasminogen activator lysis protocol to resolve the issue.The following day on (b)(6) 2021, the patient experienced two more episodes of ventricular tachycardia that required defibrillation to resolve.The patient was given lidocaine during this time.The patient's sputum was found to be positive for staphylococcus and was given antibiotics.At this time, the medical team began the discussion of palliative care.On (b)(6) 2021 it was noted that the patient's temperate had spiked to 103f overnight and cultures were taken, but this morning on (b)(6) 2021 am today temp normal.It was noted that the patient was blinking, but not responding to verbal commands.On (b)(6) 2024, it was noted the patient had a fever of 103f that spiked overnight and the patient had seizures as a result.Cultures and sent to lab.Lidocaine was stopped this morning and patient has gone into an agonal rhythm.The family of the patient made the decision to withdraw care, therapy was discontinued and the patient expired.There was no report of association between the impella and the fever and sepsis, however it is unknown and the impella cannot be ruled out as contributing to the patient's sepsis.With impella related adverse events and malfunction occurring throughout the patient's therapy, impella cannot be ruled out as a contributing factor to the patient's outcome.

• Brand Name: IMPELLA 5.0
• 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 ; 22 cherry hill dr.; danvers, MA 01923
• MDR Report Key: 20929536
• Report Number: 1220648-2024-24770
• Device Sequence Number: 8319996
• Product Code: OZD
• UDI-Device Identifier: 00813502011180
• UDI-Public: (01)00813502011180(10)2022060109(17)230331
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 12/13/2024

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: 03/31/2023
• Device Model Number: IMPELLA 5.0 AIC PUMP SET US
• Device Catalogue Number: 005062-RO
• Device Lot Number: 2022060109
• 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: 08/21/2021
• Initial Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2021
• 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: Life Threatening; Death; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White