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 Code	Thrombocytopenia (4431)
Date of Event	08/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical narrative: an impella cp was inserted via right femoral artery access in a male patient of undocumented age presenting with acute myocardial infarction and cardiogenic shock.The patient's clinical condition prior to support initiation was reported as scai shock stage e.Prior to impella cp implantation, the patient was receiving extracorporeal membrane oxygenation (ecmo) as the primary support modality, as well as inotropes, vasopressors, and respiratory support.The impella cp was utilized for left ventricular venting during ecmo support.One day after implantation, a purge cassette malfunction was identified when a purge occlusion alarm was displayed on the automated impella controller.The purge cassette was removed and replaced.Following replacement, purge pressure and purge flow returned to appropriate levels.There was no interruption in hemodynamic support and no reported patient injury related to the event.During the course of support, the treating team also expressed concerns for possible heparin-induced thrombocytopenia (hit).As a precaution, the purge solution was changed to sodium bicarbonate and systemic anticoagulation was transitioned to argatroban.Platelet count information sufficient to confirm the onset of hit were not reported.Throughout support, the device was reported to function as intended at performance level p-8 with a flow rate of 3.3 l/min using a purge solution of 5% dextrose in water with sodium bicarbonate.After 6 days of support, the impella cp was successfully weaned and explanted.Whether the patient remained on ecmo support was not reported.No additional intervention beyond purge cassette replacement and modification of anticoagulation management was required.There was no identified clinical adverse event identified with the purge event.
Additional Manufacturer Narrative
The device is available for return.This is one of two related reports.This report represents the impella cp and another report will be submitted to represent the purge cassette.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 (Section G): Danvers
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; +1(781)493-4967
• MDR Report Key: 50435885
• Report Number: 1220648-2026-11954
• Device Sequence Number: 21438344
• Product Code: OZD
• UDI-Device Identifier: 00813502011371
• UDI-Public: (01)00813502011371(17)280204(10)2027904903
• 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: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,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: 0048-0024-JP
• Device Lot Number: 2027904903
• 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: 08/11/2026
• Initial Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/18/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Extra Corporeal Membrane Oxygenation.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Race: Asian