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

Catalog Number	2000171
Medical Device Problem Code	Priming Problem (4040)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2026
Type of Reportable Event	Death
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
Clinical narrative: an impella cp device was inserted via the left femoral artery in a 37-year-old male patient presenting with acute myocardial infarction complicated by cardiogenic shock (ami/cgs), scai shock stage e, with a history of diabetes mellitus.During support, an ¿air in purge system¿ alarm persisted despite use of the de-airing protocol on two occasions.The customer replaced the complete purge cassette system, after which the alarm resolved.The patient subsequently expired while on support.The reported cause of death was cardiac arrest unrelated to the purge cassette issue.The patient had experienced an infarction approximately five hours prior to impella cp insertion.The reported events are priming problem, device revision or replacement, and death.The device will be conservatively reported for death; however, the death is most likely attributable to the severity of the underlying acute myocardial infarction and cardiogenic shock associated with scai shock stage e.
Additional Manufacturer Narrative
B2 required intervention was selected as it was omitted from the initial report that was submitted.D6a and d6b implant and explant dates were reported on the initial report and should not of been as purge cassettes are not implantable devices.
Additional Manufacturer Narrative
Added: d3.Priming problem: the cause of priming problem was unable to be determined as limited clinical details were provided and no product was returned for review.

• 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): ABIOMED EUROPE GMBH; neuenhofer weg 3; aachen 52074 ; GM 52074
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24740830
• Report Number: 1220648-2026-06143
• Device Sequence Number: 9060575
• Product Code: OZD
• UDI-Device Identifier: 00813502012477
• UDI-Public: (01)00813502012477(17)281130(10)2041972
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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,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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 2000171
• Device Lot Number: 2041972
• 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: 03/23/2026
• Supplement Date Received by Manufacturer: 05/18/2026; 05/21/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 05/21/2026; 05/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2026
• 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; Required Intervention
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 89 KG