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

Catalog Number	1000323
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemolysis (1886)
Date of Event	08/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical narrative: an impella rp flex device was inserted into the right internal jugular vein in a 33-year-old female patient presenting in right heart failure due to cardiomyopathy secondary to myocarditis.Prior to impella support, the patient was classified as society for cardiovascular angiography & interventions (scai) stage e shock, indicating that the body was failing to respond to maximal life-saving therapies, leading to full organ shutdown.The patient was receiving multiple inotropes and vasopressors and ventilatory support.The patient's past medical history includes coronary artery disease (cad).The impella rp flex was inserted for right ventricular support as part of bipella therapy in conjunction with an impella cp.Upon transfer to a new facility on day 1 of support, gross hemolysis was reported along with ¿placement signal low¿ alarms.Bedside point-of-care ultrasound (pocus) was performed, and the impella rp flex was retracted approximately 5 cm.Following repositioning, the device waveforms improved.A formal echocardiogram was planned for further evaluation.Despite repositioning, the reported hemolysis did not resolve.No plasma-free hemoglobin and lactate dehydrogenase (ldh) values were reported.After approximately 20 hours of support, the impella rp flex was removed, and the patient remained on impella cp support.No adverse clinical consequences were reported.Throughout support, the impella rp flex functioned within expected operating parameters at performance level p-8 with reported flows of approximately 3.2 l/min utilizing a d5w sodium bicarbonate purge solution.The post-procedure outcome is survived at explant.Based on the available information, the reported hemolysis may have been associated with suboptimal impella rp flex positioning.Despite repositioning, hemolysis persisted, suggesting that additional patient-specific factors may have contributed, including severe right heart failure, myocarditis, and the use of multiple mechanical circulatory support devices, which is associated with an increased risk of shear stress on red blood cells.
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 Right Heart Support Blood Pump
• Manufacturer (Section D): Abiomed, Inc. - 1220648; 22 cherry hill drive; danvers MA 01923
• Manufacturer (Section G): Danvers
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; +1(781)493-4967
• MDR Report Key: 50689809
• Report Number: 1220648-2026-12620
• Device Sequence Number: 9684450
• Product Code: PYX
• UDI-Device Identifier: 00813502012811
• UDI-Public: (01)00813502012811(17)270531(10)2026794760
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P170011
• 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

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 Catalogue Number: 1000323
• Device Lot Number: 2026794760
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/19/2025
• 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: Other
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 140 LB
• Patient Race: White