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

Catalog Number	0048-0024-JP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	03/12/2026
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 rationale: a 70 year old male patient underwent placement of an impella cp device hemodynamic support in the setting of acute myocardial infarction and cardiogenic shock.The device was implanted percutaneously via femoral arterial access on (b)(6) 2026 at 20:30.Following impella cp placement and pre pci preparation in the culprit lad, the patient developed cardiac tamponade upon clinical reassessment.An emergency surgical intervention was initiated.Additional information received on 2026/03/16 confirmed that the surgical procedure was performed with both the impella cp and ecmo in place.An open chest approach was utilized, during which a cardiac rupture closure procedure was successfully completed.The customer reported that this incident is a mechanical complication of mi and is not related to impella.The patient remains in the icu on ongoing impella and ecmo support, and explant has not yet occurred.Based on the clinical course and available information, the event is consistent with a known mechanical complication of myocardial infarction.There is no evidence suggesting that the impella cp device caused or contributed to the cardiac rupture or tamponade.The patient remains on support at the time of reporting.
Additional Manufacturer Narrative
Additional information received regarding the patient outcome the following were updated.B2 death and date of death.B5 clinical rationale.D6b explant date.H1 and h6.
Event or Problem Description
A 70 year old male patient underwent placement of an impella cp device hemodynamic support in the setting of acute myocardial infarction and cardiogenic shock.The device was implanted percutaneously via femoral arterial access on (b)(6) 2026 at 20:30.Following impella cp placement and pre pci preparation in the culprit lad, the patient developed cardiac tamponade upon clinical reassessment.An emergency surgical intervention was initiated.Additional information received on 2026/03/16 confirmed that the surgical procedure was performed with both the impella cp and ecmo in place.An open chest approach was utilized, during which a cardiac rupture closure procedure was successfully completed.The customer reported that this incident is a mechanical complication of mi and is not related to impella.Based on the clinical course and available information, the event is consistent with a known mechanical complication of myocardial infarction.The patient expired on (b)(6) 2026 with the cause of death listed as decreased cardiac function due to cardiac rupture.The death is conservatively being reported although an unlikely contributing factor to the death, and more likely the patient's presenting native critical condition.
Additional Manufacturer Narrative
Investigation summary: ppae (cardiac tamponade): the cause of the injury was not determined due to insufficient clinical details.

• Brand Name: IMPELLA CP SMART ASSIST SET, JP
• 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: 24627912
• Report Number: 1220648-2026-05570
• Device Sequence Number: 8688787
• Product Code: OZD
• UDI-Device Identifier: 00813502011371
• UDI-Public: (01)00813502011371(17)270731(10)2026746134
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/21/2026

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: 2026746134
• 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: 03/12/2026
• Supplement Date Received by Manufacturer: 03/24/2026; 04/09/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 03/30/2026; 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2025
• 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; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian