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

Catalog Number	0042-0040-US
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An impella cp with smartassist (sa) was inserted via the right femoral artery in a 42-year-old male weighing 127 kg and measuring 188 cm in height.The patient presented with acute myocardial infarction complicated by cardiogenic shock.Comorbidities were not reported.The patient's clinical state prior to initiation of support was society for cardiovascular angiography and interventions (scai) shock stage d identified when there is evidence of shock that worsens or fails to improve despite escalation therapies.Prior to impella support, the patient was receiving inotropes, vasopressors, and respiratory support.Device course & treatment: during implantation, a 0.035-inch guidewire was unable to make the turn into the aortic arch and a 0.018-inch guidewire was subsequently used for aortic valve assessment.While the guidewire was being advanced, it contacted the impella motor, resulting in fraying and fracture of the wire.During removal, the guidewire became entangled within the mitral valve chordae and subsequently fractured.Multiple attempts were made to snare the fractured guidewire fragment, which was ultimately successfully retrieved and removed from the patient.The impella cp with smartassist remained in position and support was continued.The day following implant, the patient was transferred from an outside hospital.During an automated impella controller (aic) to aic transfer, the impella cp sa controller displayed the alarms "placement signal not reliable" and "placement monitoring disabled." the controller displayed only the motor current waveform, and placement signal and left ventricular values were unavailable.The clinical team transferred the pump to another aic controller, after which placement information returned and pump operation normalized.The following day, the impella cp with smartassist remained on support at performance level 5 with flows of 2.8 l/min and a mean motor current of 520 ma.The pump was reported to be performing adequately, and the patient remained on support at the time of reporting.Additional factors: the patient's acute myocardial infarction and scai stage d cardiogenic shock requiring inotropic, vasopressor, and respiratory support represent significant clinical factors in the patient's overall condition.The guidewire fracture occurred after contact between the guidewire and impella motor during advancement.Following retrieval of the fractured guidewire segment, the impella remained appropriately positioned and continued to provide support.No concomitant devices were reported.Device contribution: the impella cp with smartassist is considered a contributing factor to the reported guidewire fracture, as the guidewire contacted the impella motor during advancement, resulting in fraying and subsequent fracture.The reported placement signal alarms were limited to a single automated impella controller and resolved following transfer to a second controller, after which normal pump operation and placement monitoring resumed.The impella cp with smartassist remained on support throughout the reported events.No persistent performance issues, interruption of support, or additional device malfunctions were reported.
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: 50936087
• Report Number: 1220648-2026-13476
• Device Sequence Number: 10722324
• Product Code: OZD
• UDI-Device Identifier: 00813502011401
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 09/29/2026

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: 0042-0040-US
• Device Lot Number: 1607654
• 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: 09/22/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 279 LB
• Patient Race: White