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	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	05/10/2026
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
An impella cp device was inserted via the right femoral artery in a 59-year-old male patient for the indication of acute myocardial infarction complicated by cardiogenic shock, presenting in society for cardiovascular angiography and interventions (scai) stage c shock.Following impella cp placement, the patient developed loss of distal pulse in the right lower extremity (right pedal pulse), and the right leg was noted to be cool to touch, consistent with limb ischemia.The ischemia was reported to have begun during or after insertion of the repositioning unit.At the time of the event, the patient was receiving norepinephrine (levophed), reflecting ongoing hemodynamic support requirements.At the time of reporting, no interventions had been performed for the limb ischemia and no additional information was available regarding further management.The patient was escalated to impella 5.5 support for ongoing hemodynamic instability.The reported limb ischemia is consistent with known risks associated with large-bore femoral arterial access and the use of mechanical circulatory support in critically ill patients requiring vasopressor therapy, which may contribute to reduced distal perfusion.Two days later, care was withdrawn and the patient expired.The death is being conservatively reported; however, based on the available information, the death is most likely attributable to the patient¿s underlying acute myocardial infarction, cardiogenic shock (scai stage c), and need for vasopressor support, reflecting the severity of the patient¿s critical clinical condition.
Event or Problem Description
Clinical narrative (updated): additional information was received indicating that a distal perfusion catheter was placed to restore flow, after which the patient was escalated to impella 5.5 support.An impella cp device was inserted via the right femoral artery in a 59-year-old male patient for the indication of acute myocardial infarction complicated by cardiogenic shock, presenting in society for cardiovascular angiography and interventions (scai) stage c shock.Following impella cp placement, the patient developed loss of distal pulse in the right lower extremity (right pedal pulse), and the right leg was noted to be cool to touch, consistent with limb ischemia.The ischemia was reported to have begun during or after insertion of the repositioning unit.At the time of the event, the patient received norepinephrine (levophed), reflecting ongoing hemodynamic support requirements.At the time of reporting, no interventions had been performed for the limb ischemia and no additional information was available regarding further management.The patient was escalated to impella 5.5 support for ongoing hemodynamic instability.The reported limb ischemia is consistent with known risks associated with large-bore femoral arterial access and the use of mechanical circulatory support in critically ill patients requiring vasopressor therapy, which may contribute to reduced distal perfusion.Two days later, care was withdrawn and the patient expired.The death is being conservatively reported; however, based on the available information, the death is most likely attributable to the patient's underlying acute myocardial infarction, cardiogenic shock (scai stage c), and need for vasopressor support, reflecting the severity of the patient¿s critical clinical condition.
Additional Manufacturer Narrative
Additional information b5 was updated and h6 code f1905 and f19 were added.
Additional Manufacturer Narrative
H6: updated codes based on the results of the investigation.H11: updated based on the results of the investigation and added clinical review.Corrected information has been provided in d3 (manufacturer fax).Upon review, it was identified that the information was inadvertently not submitted in the initial report.The cause of the injury was not 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: 25201812
• Report Number: 1220648-2026-07956
• Device Sequence Number: 21051051
• Product Code: OZD
• UDI-Device Identifier: 00813502011876
• UDI-Public: (01)00813502011876(17)270531(10)2026744971
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,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: 2026744971
• 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: 05/10/2026
• Supplement Date Received by Manufacturer: 05/18/2026; 06/02/2026
• Initial Report FDA Received Date: 05/18/2026
• Supplement Report FDA Received Date: 05/21/2026; 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2025
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White