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	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thromboembolism (2654)
Date of Event	04/30/2026
Type of Reportable Event	Death
Event or Problem Description
Clinical narrative: an impella cpsa device was inserted into the right femoral artery in a 77-year-old female patient presenting in scai stage a shock.The impella was inserted for ventricular support for a high-risk cardiac surgery: ventricle septal (vs) repair procedure.During the procedure, a thrombus formed on the shaft of the impella prior to the vs procedure.After three days on support, the device was removed with an escalation of therapy to an impella 5.5.After removal, the thrombus remained in the descending aorta.The patient was transferred to cardiopulmonary bypass.Subsequently, the thrombus moved, requiring a thrombectomy.The post-procedure outcome is survived at explant.The impella functioned at p-2 at 0.9l/min as intended.Thrombus (thrombosis) can occur due to inadequate anticoagulation, and is an adverse event associated with impella's mechanical support.
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 root cause of the injury was unable to be determined due to insufficient clinical details.
Event or Problem Description
Clinical narrative (updated): additional information noted that the patient expired while on the second pump.The device will be conservatively reported for death; however, the death is most likely attributed to the patient¿s underlying critical clinical condition.An impella cpsa device was inserted into the right femoral artery in a 77-year-old female patient presenting in scai stage a shock.The impella was inserted for ventricular support for a high-risk cardiac surgery: ventricle septal (vs) repair procedure.During the procedure, a thrombus formed on the shaft of the impella prior to the vs procedure.The thrombus was noticed on transesophageal echocardiogram (tee) in the operating room prior to the vsp repair procedure.After three days on support, the device was removed with an escalation of therapy to an impella 5.5.After removal, the thrombus remained in the descending aorta.The patient was transferred to cardiopulmonary bypass.Subsequently, the thrombus moved, requiring a thrombectomy.The vsp repair procedure was postponed to a later time.The post-procedure outcome is survived at explant.The impella functioned at p-2 at 0.9 l/min as intended.Thrombus (thrombosis) can occur due to inadequate anticoagulation, and is an adverse event associated with impella's mechanical support.
Additional Manufacturer Narrative
Additional information received regarding patient outcome of death.The following were updated to reflect the patient death.B2, b5, h1, h6.
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.
Additional Manufacturer Narrative
Additional information was provided b3 event date was updated and b5 clinical narrative was updated.
Event or Problem Description
Updated clinical narrative: an impella cpsa device was inserted into the right femoral artery in a 77-year-old female patient presenting in scai stage a shock.The impella was inserted for ventricular support for a high-risk cardiac surgery: ventricle septal (vs) repair procedure.During the procedure, a thrombus formed on the shaft of the impella prior to the vs procedure.The thrombus was noticed on transesophageal echocardiogram (tee) in the operating room prior to the vsp repair procedure.After three days on support, the device was removed with an escalation of therapy to an impella 5.5.After removal, the thrombus remained in the descending aorta.The patient was transferred to cardiopulmonary bypass.Subsequently, the thrombus moved, requiring a thrombectomy.The vsp repair procedure was postponed to a later time.The post-procedure outcome is survived at explant.The impella functioned at p-2 at 0.9l/min as intended.Thrombus (thrombosis) can occur due to inadequate anticoagulation, and is an adverse event associated with impella's mechanical support.

• 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: 25092621
• Report Number: 1220648-2026-07553
• Device Sequence Number: 13259475
• Product Code: OZD
• UDI-Device Identifier: 00813502011371
• UDI-Public: (01)00813502011371(17)271031(10)2026800167
• 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,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: 0048-0024-JP
• Device Lot Number: 2026800167
• 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: 04/30/2026
• Supplement Date Received by Manufacturer: 05/07/2026; 05/24/2026; 05/29/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 05/14/2026; 05/27/2026; 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2025
• 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: Required Intervention; Death
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 44 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian