MAUDE Adverse Event Report: Abiomed, Inc. - 1220648 Impella; Temporary Non-Roller Type Left Heart Support Blood Pump

Catalog Number	1000080
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/22/2026
Type of Reportable Event	Death
Event or Problem Description
An impella cp smartassist was inserted percutaneously via right femoral access site in 62-year-old male patient (weight 72 kilograms and height 165cm) for cardiomyopathy.The patient¿s comorbidities were coronary artery disease (cad), diabetes mellitus, renal insufficiency and dialysis.The patient¿s clinical state prior to initiation of support was society for cardiovascular angiography intervention (scai) shock stage e identified as the body fails to respond to maximal lifesaving therapies.Concurrent continuous renal replacement therapy (crrt).The patient was on inotropes, vasopressors and respiratory support.Device course & treatment: on day 3 of support, hospital staff reported that the patient became delirious and moved during support, resulting in the impella catheter being pulled back.Subsequently, impella in aorta alarms were observed, and bleeding was noted at the groin access site.Transthoracic echocardiography reportedly confirmed that the pump had migrated completely out of the left ventricle and into the aorta.Hospital personnel contacted abiomed for clinical guidance regarding management of the bleeding and potential administration of protamine and platelets.They were advised that there was no impella-specific contraindication to protamine or platelet administration and that treatment decisions should be made by the clinical team.Manual pressure in accordance with the instructions for use was recommended.The bleeding was reported to be associated with the access site arteriotomy/vessel following patient movement and device displacement.Additional information regarding anticoagulation monitoring, antithrombotic therapy, blood loss volume, blood products administered, and method of hemostasis was not provided.Before further follow-up could occur, the patient experienced a code event and subsequently expired while on support.The pump position issue was reported as the device being pulled out of position following patient movement.Additional factors: the pump was pulled back and device migrated completely out of the left ventricle.Hemoglobin of 7.9 and hematocrit 23.5.However, the contribution of concomitant systemic anticoagulation, vasopressor therapy, severe cardiogenic shock, and the patient's underlying critical illness cannot be excluded as contributing factors, patient movement.Device contribution: based on the available information, the event was associated with patient movement leading to device displacement and subsequent access-site bleeding.The access site bleed is a procedural complication that is associated with large bore access.Contributing factors include, underlying (scai) shock stage e when the body fails to respond to maximal lifesaving therapies, the patient hemoglobin was 7.9 and the hematocrit was 23.5.The pump had migrated completely out of the left ventricle and into the aorta providing no hemodynamic support likely contributed to the patients death.
Additional Manufacturer Narrative
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.

• 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 ; +1(781)493-4967
• MDR Report Key: 50936618
• Report Number: 1220648-2026-13477
• Device Sequence Number: 18826255
• Product Code: OZD
• UDI-Device Identifier: 00813502012279
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 1000080
• Device Lot Number: 2027939590
• 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: 09/22/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2026
• 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; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 158 LB
• Patient Race: Black Or African American