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

Model Number	IMPELLA 5.0
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2021
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 with cardiomyopathy was to be implanted with an impella 5.0 for mechanical circulatory support.It was reported that the patient presented with covid-like symptoms on (b)(6) 2021.Upon arrival, the patient coded three times in twenty-four hours.An electrocardiogram performed noted an anterior non-st elevation myocardial infarction.The patient was brought to the cardiac catheterization laboratory but was surgically turned down.The decision was then made to transfer the patient to another hospital but coded as soon as the transport team arrived and was denied.A return of spontaneous circulation was achieved.On (b)(6) 2021, ten days after admission, the 5.0 impella was decided to be placed to stabilize the patient for transfer.The impella 5.0 insertion was aborted due to the patient's vascular anatomy.The physician then decided to place an impella cp into the axillary artery, and the delivery was successful.The patient remained unstable, did not improve and expired three days later.The cp device was noted to have worked as expected.Given the inability to deliver the 5.0 device, the patient underwent additional intervention to place the impella cp and this could have contributed to the patient's outcome although the patient expired three days later.Therefore, conservatively reporting as vessels characteristics more likely have impacted the event.Immediate needed support was unable to be delivered due to patient's vascular anatomy.

• 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.; neuenhofer weg 3; aachen MA 52074 ; GM 52074
• Manufacturer Contact: derek sammarco ; 22 cherry hill dr.; danvers, MA 01923
• MDR Report Key: 20813671
• Report Number: 1220648-2024-24447
• Device Sequence Number: 9807089
• Product Code: OZD
• UDI-Device Identifier: 00813502011180
• UDI-Public: (01)00813502011180(10)2022088789(17)230531
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/30/2024

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: 05/31/2023
• Device Model Number: IMPELLA 5.0
• Device Catalogue Number: 005062
• Device Lot Number: 2022088789
• 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: 10/23/2021
• Initial Report FDA Received Date: 11/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2021
• 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: Death
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White