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

Catalog Number	0042-0000-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	09/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An impella 5.5 with smartassist (sa) was inserted via the right axillary/subclavian artery in a 65-year-old female weighing 83 kg.The patient presented with acute myocardial infarction complicated by cardiogenic shock and cardiac arrest requiring cardiopulmonary resuscitation.Comorbidities were not reported.The patient's clinical state prior to initiation of support was society for cardiovascular angiography and interventions (scai) stage e cardiogenic shock, identified by refractory shock in which the body is failing to respond to maximal lifesaving therapies with progressive end-organ dysfunction.Prior to impella support, the patient was receiving extracorporeal membrane oxygenation (ecmo), inotropes/vasopressors, and respiratory support.Ecmo was the primary hemodynamic support modality.The impella 5.5 with smartassist was utilized for left ventricular venting and unloading while ecmo remained the primary hemodynamic support modality.While preparing for implantation and initiation of support, the initial automated impella controller (aic) did not recognize the purge cassette/purge disc.The same purge cassette was subsequently connected to a second aic and functioned without issue.The initial aic was never connected to the impella pump.The aic was exchanged prior to connecting the pump and support was initiated using the replacement controller.Therefore, no interruption of therapy or patient support occurred as a result of the reported purge cassette recognition issue.No additional alarms, malfunctions, or unanticipated device-related issues were reported.The following day, due to the patient's poor prognosis, care was withdrawn and the patient expired.During support, the impella 5.5 with smartassist functioned as intended while operating at p4 with flows of approximately 3.0 l/min.The purge solution consisted of dextrose 5% in water (d5w) with 25 meq/l sodium bicarbonate.No additional alarms, device malfunctions, or unanticipated device-related issues were reported the death is not related to the reported purge cassette recognition issue.The initial automated impella controller (aic) was exchanged before the impella pump was connected, and the same purge cassette functioned as intended on the replacement controller.As support had not yet been initiated when the event occurred, there was no interruption of therapy, loss of support, or reported adverse clinical consequence associated with the event.The impella 5.5 with smartassist subsequently functioned as intended with no additional alarms, malfunctions, or unanticipated device-related issues reported.The death is attributed to the patient's underlying acute myocardial infarction, refractory society for cardiovascular angiography and interventions (scai) stage e cardiogenic shock, cardiac arrest requiring cardiopulmonary resuscitation, and the need for extracorporeal membrane oxygenation as the primary hemodynamic support modality.Therefore, there is no indication that the impella device, purge cassette, or reported controller recognition issue caused or contributed to the death outcome.
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 Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; +1(781)493-4967
• MDR Report Key: 50914104
• Report Number: 1220648-2026-13393
• Device Sequence Number: 5394527
• Product Code: OZD
• UDI-Device Identifier: 00813502010022
• UDI-Public: (01)00813502010022(11)121228(10)1122786
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Physician
• 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: 0042-0000-US
• Device Lot Number: 1122786
• 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: 09/19/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/28/2012
• 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: extracorporeal membrane oxygenation.
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 182 LB
• Patient Race: White