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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/02/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
The impella device was not received from the customer; therefore, investigation of the device was not possible.Should the device or any new information be received, a supplemental mdr will be filed.
Event or Problem Description
An 85-year-old male with a history of acute myocardial infarction complicated by cardiogenic shock, consistent with scai shock stage d, underwent percutaneous right femoral arterial placement of an impella cp (584927) device on (b)(6) 2026 at 16:20.Anticoagulation therapy with heparin at 10 units/kg/hr was administered, with act used for anticoagulation monitoring.Following transfer from the cardiac catheterization laboratory to the intensive care unit, the patient was noted to be unsedated with significant lower extremity movement, described as kicking legs wildly.During an icu nursing assessment, active bleeding was observed at the femoral access site around the introducer sheath, with a small hematoma noted.No act value at the time of bleeding was available.The heparin infusion was promptly discontinued, and hemostasis was achieved using a femstop device, with adjunct use of 4x4 gauze.Forward suturing had been utilized, and the reposheath was confirmed to be properly placed with appropriate angle matching.Based on available information, the reported event involved access site bleeding following icu transfer, temporally associated with significant patient movement while on impella cp support and systemic anticoagulation.Hemostasis was successfully managed with cessation of heparin and femstop application.No device malfunction or failure mode was identified, and the device was not removed due to a performance issue.The patient¿s death occurred after withdrawal of care.The death is conservatively being reported to the impella cp but is unlikely related and is most likely attributed to patients underlying critical condition as they presented in scai stage d shock on multiple inotropes and pressors and was ventilated for respiratory support.
Additional Manufacturer Narrative
Corrected information was provided in d3 (manufacturer fax), e1 (zip code extension), e4 (reporter also sent report to fda?).Upon review, it was identified that it was inadvertently omitted from the initial report.Corrected information was provided in d4 (serial, primary udi number).Upon review, the section d primary udi and serial number have now been updated.H6: updated codes based on the results of the investigation.H11: updated based on the results of the investigation.The cause of the access site adverse event was user related as patient was kicking legs wildly.

• 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: 24835674
• Report Number: 1220648-2026-06591
• Device Sequence Number: 21128999
• Product Code: OZD
• UDI-Device Identifier: 00813502011876
• UDI-Public: (01)00813502011876(17)270131(10)2026647591
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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

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: 2026647591
• 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: 04/02/2026
• Supplement Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2025
• 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: Death
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White