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

Catalog Number	1000413
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An impella cp10 was inserted through a 14fr low profile sheath via the right femoral artery in a 65-year-old male patient presenting with acute myocardial infarction complicated by cardiogenic shock (ami/cgs), with a history of prior coronary artery bypass grafting.The patient¿s clinical state prior to initiation of support was identified as scai shock stage d.The patient was on peripheral veno-arterial extracorporeal membrane oxygenation (va ecmo) and cp10 support.Bilateral distal perfusion catheters (dpc) were placed at the time of device insertion.During rounds, the patient was noted to have bilateral lower extremity ecchymosis and absent distal pulses.Bilateral arterial ultrasounds showed almost zero flow for both lower extremities, despite bilateral dpc.Peripheral va ecmo was a contributing factor.The patient was taken to the cardiovascular operating room (cvor) for escalation to impella 5.5 and revision of va ecmo to protek duo.During preparation, the automated impella controller (aic) showed signs of potential pump saturation.Prior to removal of cp10, the left placement sheath (lps) was aspirated, showing no sign of thrombus.However, thrombus was noted in the hemostatic valve of the sheath during the explant process and in the side arm of the dpc.The pump was explanted successfully prior to escalation to impella 5.5.The patient survived to explant.Peripheral arterial ischemia may result from access-site vascular compromise, underlying critical illness, and the use of peripheral va ecmo.Thromboembolism may form in the setting of mechanical circulatory support, vascular access devices, and critical illness.
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
B1 selection was added as it was omitted from the initial report that was submitted.B3 revised date of event as it was entered incorrectly on the initial report that was submitted.D4 revised primary udi number as it was entered incorrectly on the initial report that was submitted.D9 device was returned and date received was added.H6 type of investigation code was updated due to the device being returned.H11 updated additional manufacturer narrative due to device being returned.The impella device was returned, and an evaluation is underway.Upon investigation closure, a supplemental report will be filed.
Additional Manufacturer Narrative
This is one of two related reports.This report represents the impella cp and another report was submitted to represent the introducer.
Additional Manufacturer Narrative
Additional information was received and noted the following: the patient was fem-fem cannulated, so impella was placed rfa and va ecmo was rfv and lfa.Lp sidearm was used as donor for dpc for impella side only, arterial cannula was used as donor for the ecmo dpc.D10: concomitant was updated accordingly.Related report number.This is one of two device reports associated with the event.Refer to h10 for the related report number(s).
Additional Manufacturer Narrative
D9: added devices return information.H6: updated codes based on the results of the investigation.H11: updated based on the results of the investigation.Investigation summary: high or saturated pump flow: the cause of the saturated pump flow was likely biomaterial due to findings on returned product but the type of interaction is unknown since field data logs were unavailable.

• 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: 25112103
• Report Number: 1220648-2026-07640
• Device Sequence Number: 18712169
• Product Code: OZD
• UDI-Device Identifier: 00813502013566
• UDI-Public: (01)00813502013566(17)271130(10)2027847350
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 1000413
• Device Lot Number: 2027847350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2026
• Supplement Date Received by Manufacturer: 05/11/2026; 05/22/2026; 05/28/2026; 06/17/2026
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 05/12/2026; 05/22/2026; 06/02/2026; 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2026
• 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: VA ECMO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White