MAUDE Adverse Event Report: ABIOMED, INC. IMPELLA 5.5; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Model Number	IMPELLA 5.5 WITH SMARTASSIST SET, US
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The complainant reported that the pump experienced an optical sensor failure after the device was repositioned during support.Both the placement signal and lv signal stopped working as a result of the failure.Patient support continued with the installed device as the motor current, flows, and purge pressure remained within acceptable limits.
Additional Manufacturer Narrative
This mdr is being submitted as part of a retrospective review of optical signal issues in accordance with fda recommendation.The returned pump was connected to an automated impella controller (aic) and placement signal not reliable reproduced.The pump was soaked and water but the alarm persisted.A loose patient cable to kink protector bond was observed with the patient cable able to rotate freely.The cause of the optical signal failure was a damaged optical fiber line during torqueing the device due to a loose patient cable to kink protector bond.A review of the device history record (dhr) for the suspect product and historical complaint data was conducted.This review revealed that the product met all manufacturing release criteria, and no product deficiencies were identified at the time the product was manufactured and released to the customer.All pertinent information available to abiomed has been submitted at this time.

• Brand Name: IMPELLA 5.5
• Common Device Name: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED, INC.; 22 cherry hill dr.; danvers MA 01923
• Manufacturer (Section G): ABIOMED, INC.; 22 cherry hill dr.; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill dr.; danvers, MA 01923
• MDR Report Key: 23348108
• Report Number: 1220648-2025-31879
• Device Sequence Number: 7807201
• Product Code: OZD
• UDI-Device Identifier: 00813502011531
• UDI-Public: (01)00813502011531(10)2023254772(17)250731
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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
• Report Date (Section B): 10/21/2025

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 Expiration Date: 07/31/2025
• Device Model Number: IMPELLA 5.5 WITH SMARTASSIST SET, US
• Device Catalogue Number: 0550-0008
• Device Lot Number: 2023254772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2022
• 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
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White