MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 IMPELLA; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Catalog Number	0048-0045
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hematoma (1884); Hemolysis (1886)
Date of Event	04/27/2026
Type of Reportable Event	Serious Injury
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.
Additional Manufacturer Narrative
This follow-up report is being submitted to document that the device has been returned to the manufacturer for investigation.Section d9 has been updated to reflect that the product was returned for investigation.
Event or Problem Description
An impella cp device was inserted into the left femoral artery in a 58-year-old male patient with a past medical history of a prior coronary artery bypass graft (cabg) and coronary artery disease (cad), presenting in post-cardiotomy cardiogenic shock (pccs) and low cardiac output syndrome (lcos), in scai stage d shock, on an intra-aortic balloon pump (iabp), on extracorporeal membrane oxygenation (ecmo), on multiple inotropes and vasopressors, and on a ventilator for respiratory support, prior to initiation of support.The impella was inserted for ventricular support during a cardiothoracic (ct) surgery: cabg.While the patient was in the intensive care unit (icu), there was a hematoma at the access site.In addition, there was suspected hemolysis due to an elevated lactase dehydrogenase (ldh), requiring blood products.The pump was noted to be in good position.It was noted that the patient also had shock liver.The hemoglobin dropped from 9 to 6.8 in an 8 hour period.Chest tube output was about 150mls.No type of bleeding was observed.After one day on support, the device was successfully weaned.The post-procedure outcome is survived at explant.The impella functioned at p-2 at 1.9l/min as intended.Bleeding (hematoma) is a known risk due to the impella's anticoagulation and purge requirements.Hemolysis may be influenced by patient-specific factors such as critical illness, underlying cardiac dysfunction, hemodynamic instability, and potential device position.
Additional Manufacturer Narrative
Added: d3, e4.Corrected: h3.Hemolysis / patient-device interaction: the cause of the hemolysis issue was not determined without sufficient undamaged returned product to perform all necessary testing and without sufficient clinical details, including data logs.Hematoma: the cause of the injury was not determined due to insufficient clinical details.

• 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 dr.; danvers, MA 01923 ; 7814934967
• MDR Report Key: 25083662
• Report Number: 1220648-2026-07500
• Device Sequence Number: 10565444
• Product Code: OZD
• UDI-Device Identifier: 00813502011876
• UDI-Public: (01)00813502011876(17)260531(10)2025544179
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• Device Catalogue Number: 0048-0045
• Device Lot Number: 2025544179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2026
• Supplement Date Received by Manufacturer: 05/07/2026; 06/22/2026
• Initial Report FDA Received Date: 05/05/2026
• Supplement Report FDA Received Date: 05/11/2026; 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2024
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 106 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White