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

Model Number	IMPELLA CP SMART ASSIST SET, JP
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that extracorporeal membrane oxygenation (ecmo) was initiated due to hemodynamic collapse.A second impella insertion was considered however, cardiac rupture occurred, preventing placement.As the rupture happened before any impella related steps such as guidewire or pigtail insertion was performed.The death was determined to be unrelated to the device.
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.
Additional Manufacturer Narrative
D1 brand name was updated.Unable to deliver or advance: the cause of the unable to deliver or advance was unable to be determined as insufficient clinical details were provided.

• 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: 24206488
• Report Number: 1220648-2026-01771
• Device Sequence Number: 13213966
• Product Code: OZD
• UDI-Device Identifier: 00813502011609
• UDI-Public: (01)00813502011609(10)2026711663(17)270430
• 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: 2025
• Device Explanted Year: 2025
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IMPELLA CP SMART ASSIST SET, JP
• Device Catalogue Number: 0048-0024-JP
• Device Lot Number: 2026711663
• 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: 09/16/2025
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2025
• 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
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian