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	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	06/02/2026
Type of Reportable Event	Death
Event or Problem Description
Anan impella cp device was inserted via an unspecified femoral arterial access site in an (b)(6) male patient presenting with acute myocardial infarction complicated by cardiogenic shock, with a pre-support clinical condition consistent with society for cardiovascular angiography and interventions (scai) stage c.The patient had multivessel acute coronary syndrome and was initially supported with an intra-aortic balloon pump; however, blood pressure could not be maintained, and the patient progressed into cardiogenic shock.The following day, support was escalated with placement of an impella cp device to treat the remaining coronary lesions.On (b)(6), the patient developed acute neurologic deterioration, including disorientation and loss of consciousness.Computed tomography (ct) imaging confirmed a cerebral hemorrhage.Given the patient's advanced age and overall clinical condition, no further interventions were pursued.The impella cp device was removed, and care was withdrawn.The patient subsequently expired.The physician reported that the cause of death was unknown, and anticoagulation parameters, including ptt, were within acceptable range.The reported intracranial hemorrhage and subsequent clinical decline occurred in the setting of advanced age, acute myocardial infarction, cardiogenic shock, and critical illness.The death is being conservatively reported in association with impella cp due to temporal relationship; however, based on the available information, the outcome is more likely attributable to the patient's underlying critical condition and cerebral hemorrhagic event rather than device performance.
Additional Manufacturer Narrative
A4 is unknown.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
Additional information received and noted the following: the physician commented that the cause of the cerebral hemorrhage is unknown.The date of death was (b)(6) (as captured in the initial reporting).The death was due to unresolved systemic circulatory failure and is not related to impella.
Additional Manufacturer Narrative
Corrected information was provided in d3 (manufacturer fax).Upon review, it was identified that it was inadvertently omitted from the initial report.H6: updated codes based on the results of the investigation.H11: updated based on the results of the investigation.The root cause of the injury was unable to be 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: 25531999
• Report Number: 1220648-2026-08925
• Device Sequence Number: 9358454
• Product Code: OZD
• UDI-Device Identifier: 00813502011371
• UDI-Public: (01)00813502011371(17)271111(10)2027864561
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,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: 0048-0024-JP
• Device Lot Number: 2027864561
• 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: 06/12/2026
• Supplement Date Received by Manufacturer: 06/18/2026; 06/29/2026
• Initial Report FDA Received Date: 06/17/2026
• Supplement Report FDA Received Date: 06/27/2026; 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2026
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 89 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian