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 Codes	Failure to Advance (2524); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	04/09/2022
Type of Reportable Event	Serious Injury
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 needing an impella 5.0 device for mechanical circulatory support.Multiple attempts were made to place the impella into position without any success.The surgeon tried to manually reposition, however the impella pigtail was caught on heart structures.The impella was unable to be removed or repositioned.The patient started to decompensate as blood pressure dropped into the 40s systolic.A decision was made to do an emergent central venoarterial extracorporeal membrane oxygenation (va-ecmo).Multiple pressors were initiated and 2 units of packed red blood cells were given.The device was removed and the procedure was aborted.

• 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
• MDR Report Key: 20813497
• Report Number: 1220648-2024-24426
• Device Sequence Number: 21157535
• Product Code: OZD
• UDI-Device Identifier: 00813502011180
• UDI-Public: (01)00813502011180(10)1492674(17)Y220630
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 11/29/2024

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: 06/30/2022
• Device Model Number: IMPELLA 5.0
• Device Catalogue Number: 005062-RO
• Device Lot Number: 1492674
• 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: 04/09/2022
• Initial Report FDA Received Date: 11/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White