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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Ventricular Fibrillation (2130); Thrombocytopenia (4431)
Date of Event	05/20/2022
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 implanted with an impella 5.5 for mechanical circulatory support.The patient had been escalated from an impella cp to the impella 5.5 as hemodynamic support need had increased.After being implanted with the impella 5.5 it was reported that the patient was bleeding from multiple sites and was transfused with blood products as a result of the bleeding.On (b)(6) 2022, the patient was diagnosed with heparin induced thrombocytopenia.It was reported the patient's platelet count was 19,000 cells per microliter.The patent was transfused with platelets and blood products.Additionally, the patient had three episodes of ventricular fibrillation and required defibrillation to resolve each episode.A family meeting was called to discuss withdrawing care.It is unknown if care was withdrawn, however it is noted that the patient expired while on support.There is not enough evidence to exclude impella as an associated factor in the patient's demise.

• 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: 20814125
• Report Number: 1220648-2024-24400
• Device Sequence Number: 9934353
• Product Code: OZD
• UDI-Device Identifier: 00813502011531
• UDI-Public: (01)00813502011531(10)2023197296(17)240229
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• 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): 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: IMPELLA 5.5
• Device Catalogue Number: 0550-0008
• Device Lot Number: 2023197296
• 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: 05/20/2022
• Initial Report FDA Received Date: 11/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2022
• 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: Life Threatening; Death; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White