MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 IMPELLA; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Catalog Number	0048-0024-JP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Embolism/Embolus (4438); Thrombosis/Thrombus (4440)
Date of Event	03/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An impella cp device was inserted via the femoral artery in a 50-year-old male patient presenting with cardiomyopathy, scai shock stage c.The patient's comorbidities were not documented.One month prior to admission, he developed exertional dyspnea and was initially treated with diuretics at a local hospital for suspected heart failure; however, his condition did not improve, prompting referral to the reporting hospital.He was diagnosed with acute heart failure accompanied by fluid retention and organ failure.On admission, blood pressure was 110/86 mmhg, heart rate 123 beats/min, and oxygen saturation 99% on room air.Echocardiography demonstrated a left ventricular ejection fraction of 15%, left-ventricular end-diastolic diameter of 57 mm, septal wall thickness of 8 mm, and posterior wall thickness of 9 mm.There was no clinical history suggestive of acute coronary syndrome or acute myocarditis.Due to findings of tissue hypoperfusion, treatment with inotropic agents and low-dose diuretics was initiated.That same night, delirium progressed to hemodynamic collapse, and combined support with extracorporeal membrane oxygenation (ecmo) and impella (ecpella) was initiated.During ecpella management, systemic heparinization was maintained with a target activated partial thromboplastin time (aptt) of 50¿70 seconds.Multiple-organ dysfunction improved; however, cardiac function did not recover.On hospital day 6, long-term mechanical circulatory support was deemed necessary, and the patient was taken to the operating room for escalation from impella cp to impella 5.5 support.Intraoperative transesophageal echocardiography identified thrombus formation in the descending aorta, with a prominent hazy echo surrounding the thrombus.The impella cp was carefully removed, and an impella 5.5 was implanted via the right subclavian artery.Immediate contrast-enhanced ct imaging showed an embolic finding in the pleural tract, without evidence of embolism in major abdominal vessels.Anticoagulation was continued, and heparin-induced thrombocytopenia (hit) antibody testing was negative.On hospital day 7, ecmo support was discontinued, and the patient remained stable on impella 5.5 alone.On hospital day 13, the patient was transferred to a transplant facility for continued care and evaluation for transplant eligibility.The patient survived to explant.The reported thrombosis is consistent with thrombus formation in the setting of severe cardiogenic shock and prolonged mechanical circulatory support, necessitating escalation of support.The reported embolism is consistent with thromboembolic phenomena occurring during critical illness and advanced heart failure with mechanical circulatory support, without evidence of major systemic embolization.
Additional Manufacturer Narrative
A4 is unknown.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by abiomed inc or its employees that the report constitutes an admission that the product, abiomed inc, or its employees, caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Investigation summary: embolism/thrombosis/ppae: the cause of the injury was not determined due to insufficient clinical details.

• Brand Name: IMPELLA
• Common Device Name: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED, INC. - 1220648; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24764831
• Report Number: 1220648-2026-06284
• Device Sequence Number: 18466389
• Product Code: OZD
• UDI-Device Identifier: 00813502011609
• UDI-Public: (01)00813502011609(17)241031(10)2023269472
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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: 10/31/2024
• Device Catalogue Number: 0048-0024-JP
• Device Lot Number: 2023269472
• 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: 03/25/2026
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2022
• 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: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian