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 Codes	Increase in Pressure (1491); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thromboembolism (2654)
Date of Event	07/28/2026
Type of Reportable Event	Death
Event or Problem Description
Clinical narrative: impella cp was percutaneously (side unspecified) femoral artery site in a 84 year-old male patient presenting with acute myocardial infarction/ cardiogenic shock.The patient¿s comorbidities were not reported.The patient¿s clinical state prior to initiation of support was society for cardiovascular angiography and interventions (scai) shock stage was not provided.While on support, the device functioned as intended at p-4 at 0.8 liter/minute with unknown purge solution.Approximately one day following implantation, a decrease in purge flow and frequent bad position alarms were observed.Despite anticoagulation management, including maintenance of activated clotting time (act) between 160-180 seconds, activated partial thromboplastin time( aptt) of approximately 50 seconds, and addition of heparin (5 u/ml) to the purge solution, thrombus formation was suspected.Due to the risk of progressive purge flow reduction and potential pump stoppage, the device was replaced.Upon explant, red thrombus was observed adherent to the pump inlet and white thrombus was noted on the impeller and outlet, with pathology evaluation planned.Blood clots were also reported in the patient.Following device replacement, the patient's hemodynamics remained unstable.Another impella cp was inserted via same femoral artery.Although escalation to extracorporeal membrane oxygenation (ecmo) was considered, a decision was made to pursue a do-not-attempt-resuscitation (dnar) approach in accordance with the family's wishes.The patient subsequently expired while supported with the replacement device.The patient¿s death is most likely attributed to the underlying critical condition due to cardiogenic shock and deteriorating condition, however, the thrombus formations and the short interruption of hemodynamic support when the pump was exchanged cannot conclusively be ruled out as a contributing factor.
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.

• 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 ; +1(781)493-4967
• MDR Report Key: 50194977
• Report Number: 1220648-2026-11433
• Device Sequence Number: 12286738
• Product Code: OZD
• UDI-Device Identifier: 00813502011371
• UDI-Public: (01)00813502011371(17)271111(10)2027865649
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 0048-0024-JP
• Device Lot Number: 2027865649
• 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: 07/27/2026
• Initial Report FDA Received Date: 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2026
• 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: 84 YR
• Patient Sex: Male
• Patient Race: Asian