MAUDE Adverse Event Report: ABIOMED, INC. IMPELLA 2.5; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Model Number	IMPELLA 2.5
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiovascular Dysfunction/Insufficiency (4445)
Date of Event	09/06/2022
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 is one of two medical device reports associated with the event.Refer to manufacturing report number 1220648-2024-24288 for pump 1 with serial number (b)(6).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 2.5 device for mechanical circulatory support.During the coronary intervention, the right coronary artery was dissected from the origin the to mid section.It was reported that during support, the impella 2.5 was not performing optimally with only 0.5lpm flows and irregular waveforms while the patient was receiving chest compressions.It was recommended to the medical team to replace the pump with either a new 2.5 impella or to escalate to an impella cp.Due to the patient's heavily calcified femoral and iliac arteries, the physician opted to replace the existing 2.5 pump with a new 2.5 impella, which is for this report.This second impella 2.5 had optimal flows for 10 minutes.The patient was reportedly completely unloading and non-pulsatile at 1.5 lpm and below, which the physician attributed to right ventricle heart failure.The decision was made to send the patient to the icu as they were hemodynamically stable at the time, however during transport the patient's pressures dropped and never recovered.The patient expired within 15 minutes of arriving at the icu.

• Brand Name: IMPELLA 2.5
• 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: 20796312
• Report Number: 1220648-2024-24292
• Device Sequence Number: 7809666
• Product Code: OZD
• UDI-Device Identifier: 00813502011081
• UDI-Public: (01)00813502011081(10)2023222901(17)231130
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 11/27/2024

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: 11/30/2023
• Device Model Number: IMPELLA 2.5
• Device Catalogue Number: 005042
• Device Lot Number: 2023222901
• 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: 09/06/2022
• Initial Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2022
• 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: 65 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White