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	Restricted Flow rate (1248)
Health Effect - Clinical Code	Thromboembolism (2654)
Date of Event	08/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An impella cp was inserted via the left femoral artery in a 56-year-old male patient undergoing planned coronary artery bypass surgery.The patient's comorbidity was known coronary artery disease.The scai shock stage prior to support initiation was not documented.Prior to impella support, the patient was receiving respiratory support.Two days after implantation, the patient's condition deteriorated with concerns for right heart failure.Extracorporeal membrane oxygenation (ecmo) was initiated as the primary support modality, and inotropic and vasopressor therapy were added.The impella cp remained in place to provide left ventricular unloading and venting during ecmo support.On day 3 of support, the impella cp experienced a sudden reduction in flow associated with suction alarms.Troubleshooting measures included reduction of the pump performance level, assessment of device position, and evaluation of volume status, all of which were reported to be appropriate.Due to the low-flow event and ongoing need for escalated circulatory support, the decision was made to explant the impella cp and upgrade support to an impella 5.5 device.At the time of explant, clot material was observed adhered to the impella cp.Anticoagulation management information during support was not reported.Prior to the low-flow event, the device had functioned as intended at performance level p-8 with a reported flow of 3.4 l/min using a purge solution consisting of 5% dextrose in water with sodium bicarbonate.Performance level was reduced to p-1 during troubleshooting; however, pump metrics at the time of the low-flow event were not available.The explant procedure and escalation to impella 5.5 support were not associated with reported patient injury or adverse clinical consequences.The patient survived the event and remained on impella 5.5 support at the time of reporting.
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: 50457368
• Report Number: 1220648-2026-12113
• Device Sequence Number: 9811135
• Product Code: OZD
• UDI-Device Identifier: 00813502011609
• UDI-Public: (01)00813502011609(17)271231(10)2027926511
• 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
• Report Date (Section B): 08/26/2026

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: 0048-0024-JP
• Device Lot Number: 2027926511
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/25/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2026
• 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: Extracorporeal Membrane Oxygenation
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Race: Asian