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	Failure to Advance (2524); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has been completed.No product was returned.Per the clinical investigation, the root cause of the delivery issue - anatomy was most likely due to patient condition.As noted in the impella instructions for use: impella 5.5 with smartassist for use during cardiogenic shock, 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).¿ section: warnings & cautions: warnings: ¿to reduce the risk of cardiac or vascular injury (including perforation) when manipulating the heart during cardiac surgery, evaluate the position of the pump using imaging guidance prior to manipulating the heart, and monitor position.[addition for 5.0, 5.5 only] in instances where the impella pump has been placed prior to performing cardiac surgery with aortic cross clamping and cardioplegic arrest, care should be taken when manipulating the heart when the pump position is fixed with application of the aortic cross clamp across the pump catheter.¿ ¿to reduce the risk of cardiac or vascular injury (including ventricular perforation) when advancing or torquing the impella, adjustments should be performed under imaging guidance.Section: warnings & cautions: warnings, section: pre-support evaluation, section: axillary insertion of the impella 5.5 catheter, section: direct aortic insertion, section: use of impella with transcatheter aortic valves: ¿to reduce the risk of cardiac injury (including ventricular perforation), physicians should exercise special care when inserting the impella catheter in patients with complex anatomy.This includes patients with known or suspected decreased ventricular cavity size, ventricular aneurysms, congenital heart disease, or compromised cardiac tissue quality in the settings of acute infarction with tissue necrosis.¿ ¿to reduce the risk of vascular injury, physicians should exercise caution when inserting the impella catheter in patients with complex peripheral vascular anatomy.This includes patients with known or suspected: unrepaired abdominal aortic aneurysm, significant descending thoracic aortic aneurysm, dissection of the ascending/ transverse/descending aorta, chronic anatomical changes in the relationship of the aorta/aortic valve/ventricular alignment, significant mobile atheromatous disease in the thoracic or abdominal aorta or peripheral vessels.¿ ¿physicians should exercise special care when inserting the impella catheter during active cardiopulmonary resuscitation (cpr).In addition, active cpr maneuvers may change the position of the impella device, introducing a risk of cardiac or vascular injury (including ventricular perforation).Check that the pump is positioned correctly in the left ventricle after cpr with echocardiography guidance.Section: warnings & cautions: cautions: ¿dilators and catheters should be removed slowly from the sheath.Rapid removal may damage the valve, resulting in blood flow through the valve.¿ section: warnings & cautions: warnings: ¿to reduce the risk of cardiac or vascular injury (including perforation) when manipulating the heart during cardiac surgery, evaluate the position of the pump using imaging guidance prior to manipulating the heart, and monitor position.¿ ¿to reduce the risk of cardiac or vascular injury (including perforation) when manipulating the heart during cardiac surgery, evaluate the position of the pump using imaging guidance.¿.
Event or Problem Description
The complainant reported that an impella 5.5 pump was unable to pass through the patient's vasculature during attempted delivery.As a result of the resistance caused by the patient's anatomy, the decision was made to abort the implant.An intra-aortic balloon pump was subsequently implanted for patient support.There was no reported patient harm.

• 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: 21623635
• Report Number: 1220648-2025-26771
• Device Sequence Number: 8510285
• Product Code: OZD
• UDI-Device Identifier: 00813502011531
• UDI-Public: (01)00813502011531(10)1494728(17)220731
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: IMPELLA 5.5
• Device Catalogue Number: 0550-0008
• Device Lot Number: 1494728
• 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: 02/17/2025
• Initial Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/08/2020
• 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
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White