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

Catalog Number	1000323
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	Thromboembolism (2654)
Date of Event	09/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical narrative: an impella rp flex smartassist was inserted percutaneously via right internal jugular vein access site in 78-year-old female patient for acute myocardial infarction/ cardiogenic shock.The patient¿s comorbidities were prior coronary artery bypass graft, coronary artery disease, diabetes mellitus, renal insufficiency.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.The patient was inotropes, vasopressors, and respiratory support.On day 1 of support, a high purge pressure alarm occurred, and the purge cassette was replaced; however, the alarm persisted.Tissue plasminogen activator (tpa) was added to the purge system.Tpa is an off-label use, used in the purge solution to mitigate the impact of biomaterial within the motor.There were no noted clinical adverse events reported due to the addition of tpa in purge.Subsequently, a purge system blocked alarm occurred.The tpa protocol was continued overnight, resulting in resolution of the alarms, after which the purge solution was returned to d5w with 25 meq sodium bicarbonate.No purge line kinks were observed, and the patient's activated clotting time (act) was reported to be between 160 and 180 seconds.The patient was noted to be in end-organ failure at the start of support and ultimately expired later that day.The death is attributed to patient's complex past medical history, declining cardiac condition with right ventricular failure, significant end-organ failure and scai shock stage e.There was no interruption of support, change in course of therapy or allegations on the impella flow accuracy, therefore the death is dissociated from the impella device.
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: 50883434
• Report Number: 1220648-2026-13290
• Device Sequence Number: 10717944
• Product Code: PYX
• UDI-Device Identifier: 00813502012811
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 1000323
• Device Lot Number: 2027853607
• 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: 09/17/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2026
• 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: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 226 LB
• Patient Race: White