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

Catalog Number	1000100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/19/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
This is one of two related reports.The is report represents the impella 5.5 and another report was submitted to represent the impella cp.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
Clinical narrative: an impella 5.5 device was inserted via the right axillary artery in a 67-year-old male patient presenting with acute myocardial infarction complicated by cardiogenic shock (ami/cgs), scai shock stage e.The patient¿s comorbidities were unknown.The patient required six units of packed red blood cells following escalation of support.Blood loss was attributed to a disconnected arterial line that leaked onto the floor and a jackson-pratt drain that pulled more than 800 ml from the axillary pocket.Another contributing factor was a loose arterial-line connection.The patient was overly anticoagulated prior to the procedure.A chest-wall hematoma was noted; the physician stated it ¿looked fine¿ and elected to continue heparin.An additional unit of blood was administered.Care was eventually withdrawn, and the patient expired.The reported major bleed and hematoma requiring blood transfusion is consistent with access-site and peri-procedural bleeding complications in the setting of anticoagulation and mechanical circulatory support.The device will be conservatively reported for death; however, the death is most likely attributable to the severity of the underlying ami/cgs and profound hemodynamic deterioration associated with scai shock stage e.
Additional Manufacturer Narrative
Added: d3.Corrected: d4 (serial).Asae/ major bleed/ hematoma : the cause of the access site adverse event was use related as the blood loss was attributed to procedural/line management factors (a-line disconnection) and access-site/pocket drainage requiring transfusion support.

• 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 ; 7814934967
• MDR Report Key: 24740676
• Report Number: 1220648-2026-06137
• Device Sequence Number: 14718562
• Product Code: OZD
• UDI-Device Identifier: 00813502012828
• UDI-Public: (01)00813502012828(17)270531(10)2026743932
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Other Health Care Professional
• Type of Report: Initial,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: 1000100
• Device Lot Number: 2026743932
• 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: 03/20/2026
• Supplement Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2025
• 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; Death
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White