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 Code	Hemolysis (1886)
Date of Event	04/30/2026
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.
Event or Problem Description
A 48-year-old male with acute myocardial infarction and cardiogenic shock, pre-support clinical condition consistent with scai shock stage d, was supported with an impella cp device implanted percutaneously via the left femoral artery on (b)(6) 2026 at 12:27 pm.During impella support, hemolysis was suspected when the patient voided dark red/tinged urine at first urination; no foley catheter was in place.No laboratory studies were obtained to confirm hemolysis.Imaging was available and used to confirm good pump position, and there were no documented anatomic abnormalities of the heart or evidence of pump contact with the mitral valve apparatus.High afterload was identified as a contributing factor, and clinical management included reduction of afterload and decreasing pump speed to p6.It was unclear whether the suspected hemolysis resolved with these interventions; however, the clinical team elected to explant the impella on (b)(6) 2026 at 9:03 am, as it was believed the device had provided the necessary overnight support.Based on the available information, the patient experienced suspected hemolysis, identified by dark/tinged urine during impella cp support, which resolved following device explant.Imaging confirmed appropriate pump position, and high afterload was considered a contributing clinical factor.No device malfunction was identified, and no organ damage occurred.Hemolysis is a known risk associated with impella cp and may be influenced by patient-specific factors such as underlying cardiac dysfunction and hemodynamic conditions.
Additional Manufacturer Narrative
Correction: this report is being submitted to correct h9.Upon further review, it was determined that the report was incorrectly associated with a recall.This information was entered in error, and with current information the event is not associated with any recall.
Additional Manufacturer Narrative
H6: updated codes based on the results of the investigation.H11: updated based on the results of the investigation and added clinical review.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 Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 25112049
• Report Number: 1220648-2026-07639
• Device Sequence Number: 10249389
• Product Code: OZD
• UDI-Device Identifier: 00813502011876
• UDI-Public: (01)00813502011876(17)270228(10)2026650861
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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

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: 0048-0045
• Device Lot Number: 2026650861
• 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: 04/30/2026
• Supplement Date Received by Manufacturer: 05/08/2026; 06/19/2026
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 05/08/2026; 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 95129
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White