MAUDE Adverse Event Report: Abiomed, Inc. - 1220648 Impella; Temporary Non-Roller Type Left Heart Support Blood Pump

Catalog Number	0042-0010-US
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Clinical narrative: impella 5.5 was inserted via right axillary surgical artery access in a 51-year-old male patient presenting with acute myocardial infarction and cardiogenic shock.The patient was classified as scai shock stage c and was receiving inotropic and vasopressor support prior to device implantation.After 7 days of support, a purge fluid leak was observed.The operator replaced the purge cassette; however, the newly installed purge disc subsequently failed.The automated impella controller (aic) was replaced and support was restored.Although there was a temporary interruption in hemodynamic support during the exchange, no patient harm, injury, or clinical sequelae were reported.After 8 days of support, the patient experienced sustained ventricular tachycardia and was successfully cardioverted.During the same period, neurological changes raised concern for a possible embolic stroke.No intervention for the neurological event was reported, and impella support was continued.On day 14, the patient's care was escalated with the addition of extracorporeal membrane oxygenation (ecmo).Throughout support, the device functioned as intended at performance level p-8 with reported flows of 4.6 l/min using a sodium bicarbonate purge solution.After 15 days of support, the impella 5.5 was successfully weaned and explanted after the patient was bridged to heart transplantation.At the time of explant, the device had been used beyond its indication of support.Based on the available information, the reported purge system issues were resolved through product replacement and did not result in lasting clinical consequences.While the patient experienced ventricular tachycardia and neurological changes during support, the available information is insufficient to establish a definitive causal relationship to the impella device or any contribution of the patient being supported by multiple devices, inclusive of the ecmo.
Additional Manufacturer Narrative
Additional information was received that the company representative was not aware of another automated impella controller with an issue in this case.Therefore, this is one of three related reports.This report represents the automated impella controller.Other reports were submitted to represent the purge cassette and the impella 5.5.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: 50472067
• Report Number: 1220648-2026-12139
• Device Sequence Number: 10062791
• Product Code: OZD
• UDI-Device Identifier: 00813502010985
• UDI-Public: (01)00813502010985(10)1410591(11)190510
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0042-0010-US
• Device Lot Number: 1410591
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/24/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/10/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Extra Corporeal Membrane Oxygenation
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 211 LB
• Patient Race: Black Or African American