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	09/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An impella rp flex with smartassist was inserted via the right internal jugular vein in a 56 year-old male patient for post-operative cardiothoracic surgery.The patient's clinical state prior to initiation of support was society for cardiovascular angiography and interventions (scai) shock stage e.Scai stage e is identified as refractory shock or actual/impending circulatory collapse when the body fails to respond to maximal lifesaving therapies, leading to full organ shutdown.The patient was additionally noted to be receiving vasopressors, inotropes, and respiratory support prior to impella implantation.The patient's medical history was notable for coronary artery bypass grafting (cabg), coronary artery disease (cad), and diabetes mellitus (dm).Approximately 10 minutes following implantation, a high purge pressure/purge system blocked alarm was reported.Purge flow was reported as decreased at 1.0 ml/hr and purge pressure was reported within range at 1060 mmhg.Troubleshooting included replacement of the purge cassette.However, the condition did not resolve.No purge line tubing kinks were observed.Activated clotting time (act) was reported at 326 seconds.Additional contributing factors included placement of the impella rp flex within an existing pulmonary artery line.Tissue plasminogen activator (tpa) was subsequently administered through the purge system as an off-label use for the hpp to mitigate impact of biomaterial within the motor.Although the condition was reported as not being resolved, the following day purge flow improved to 3.8 ml/hr and purge pressure decreased to 664 mmhg, both within expected operating parameters.The tpa was subsequently discontinued.No additional adverse events were reported.While on support, the impella rp flex with smartassist operated at performance level 6 with expected flows of 2.7 liters per minute.The purge solution consisted of dextrose 5% in water with 25 milliequivalents per liter of sodium bicarbonate.The reported high purge pressure/purge system blocked alarm cannot be ruled out as related to the impella rp flex device, as the condition occurred during support and resulted in subsequent administration of tpa.Additional contributing factors include placement of the rp flex within an existing pulmonary artery line.
Additional Manufacturer Narrative
Product complaint # (b)(4).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 Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; +1(781)493-4967
• MDR Report Key: 50694727
• Report Number: 1220648-2026-12649
• Device Sequence Number: 9654918
• Product Code: PYX
• UDI-Device Identifier: 00813502012811
• UDI-Public: (01)00813502012811(17)270131(10)2026690455
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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: 1000323
• Device Lot Number: 2026690455
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/21/2025
• 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: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 264 LB
• Patient Race: White