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 Codes	Restricted Flow rate (1248); Malposition of Device (2616)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	12/05/2021
Type of Reportable Event	Death
Event or Problem Description
The complainant reported a patient in non-st elevation myocardial infarction with hypotension, acute severe mitral regurgitation, and low ejection fraction was implanted with an impella 5.5 device for mechanical circulatory support to stabilize and unload the patient's left heart.During delivery of the impella into the left ventricle, the impella 5.5 was placed directly info the papillary wall and was unable to be moved.The medical team was advised to pull the guidewire, and then turn the impella as there was suspicion the guidewire was in the chordae.The patient then went into bradycardia and lost blood pressures.The impella 5.5 was successfully turned towards the apex after removal of the guidewire and support was then initiated.It was noted by the physician they believe that the patient's pressures dropped due to the right coronary artery being completely blocked and having no perfusion.During support, there were suction alarms.The power level of the impella 5.5 was dropped from p9 to p8 and the patient was given fluid volume to resolve the alarms.The patient remained on support for 5 days, and it was determined the patient was unlikely to survive any further revascularization and the decision was made to withdraw care.Care was withdrawn, and the patient expired.Although the patient's presenting condition may be more likely have impacted the event the impella cannot be excluded as a possible contributing factor in the patient's demise.
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.Impella 5.5 with smartassist for use during cardiogenic shock and high-risk pci instructions for use for the related event are as follows: section: potential adverse events (united states): "acute renal dysfunction, aortic valve injury, bleeding, cardiogenic shock, cerebral vascular accident/stroke, death, hemolysis, limb ischemia, myocardial infarction, renal failure, thrombocytopenia and cardiac or vascular injury (including ventricular perforation)." this report is being filed as part of a retrospective review of historical records.

• 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: 21732384
• Report Number: 1220648-2025-27107
• Device Sequence Number: 8635547
• Product Code: OZD
• UDI-Device Identifier: 00813502011531
• UDI-Public: (01)00813502011531(10)2022113536(17)230731
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 03/31/2025

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: 07/31/2023
• Device Model Number: IMPELLA 5.5
• Device Catalogue Number: 0550-0008
• Device Lot Number: 2022113536
• 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: 12/05/2021
• Initial Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2021
• 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: 79 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White