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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	03/28/2026
Type of Reportable Event	Death
Event or Problem Description
Clinical narrative: an impella cp was inserted via the femoral artery to support the 70 year old male patient who had been admitted in with indication of acute myocardial infarction and cardiogenic shock.The underlying history was not shared.The pump was supporting along with extra-corporeal membrane oxygenation (ecmo).While on support the cp accessed limb had lost pulses, and so to troubleshoot and treat the ischemia an antegrade puncture was made for perfusion.Additionally the ecmo accessed limb was ischemic.The team did acknowledge the vessels to be small in diameter.After just over 1 day of support the patient expired.The death is conservatively being reported although an unlikely contributing factor to the death, and more likely the patient's presenting native critical condition.Ischemia may be influenced by patient-specific factors such as severe peripheral vascular disease, underlying critical illness, hemodynamic instability, and vascular access characteristics.
Additional Manufacturer Narrative
A4 weight 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
Updated information: b5 clinical narrative updated.
Event or Problem Description
Clinical narrative: an impella cp was inserted via the femoral artery to support the 70 year old male patient who had been admitted in with indication of acute myocardial infarction and cardiogenic shock.The underlying history was not shared.The pump was supporting along with extra-corporeal membrane oxygenation (ecmo).While on support the cp accessed limb had lost pulses, and so to troubleshoot and treat the ischemia an antegrade puncture was made for perfusion.It was reported there was no improvement in limb ischemia.Additionally the ecmo accessed limb was ischemic.The team did acknowledge the vessels to be small in diameter.After just over 1 day of support the patient expired.The death is conservatively being reported although an unlikely contributing factor to the death, and more likely the patient's presenting native critical condition.Ischemia may be influenced by patient-specific factors such as severe peripheral vascular disease, underlying critical illness, hemodynamic instability, and vascular access characteristics.
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 in d10(concomitant med products) 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 (Section G): DANVERS
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24799772
• Report Number: 1220648-2026-06454
• Device Sequence Number: 9944621
• Product Code: OZD
• UDI-Device Identifier: 00813502011371
• UDI-Public: (01)00813502011371(17)271111(10)2027820869
• 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): 04/27/2026

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: 2027820869
• 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: 03/31/2026
• Supplement Date Received by Manufacturer: 04/21/2026; 04/30/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 04/27/2026; 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EXTRA-CORPOREAL MEMBRANE OXYGENATION
• Outcome Attributed to Adverse Event: Death
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian