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

Model Number PUMP SET, PUMP 381 (US)

Device Problems Restricted Flow rate (1248); Deformation Due to Compressive Stress (2889); Improper Flow or Infusion (2954)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/20/2024

Event Type  malfunction  

Manufacturer Narrative

The impella device was not received from the customer at the time of this mdr writing, and therefore, an evaluation of the device was not possible.Upon investigation closure, a supplemental mdr will be filed.

Event Description

The user facility reported a 75-year-old female noted as high risk percutaneous coronary intervention was implanted with an impella device for mechanical circulatory support.The admitting diagnosis was congestive heart failure and non-st-segment elevation myocardial infarction.The impella device was placed; however, the physician noted the positioning was "a little deep." the pump was pulled back, and low flow was observed.Fluoroscopy was checked, and it was noted the cannula was kinked.The physician attempted to advance the catheter and pull back to reduce the kinked area, which was unsuccessful.Therefore, the physician elected to remove the pump and place a new one.There was no report of adverse effect to the patient.

• Brand Name: IMPELLA CP
• Type of Device: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED, IINC.; 22 cherry hill dr.; danvers MA 01923
• Manufacturer (Section G): ABIOMED, INC.; 22 cherry hill dr.; danvers MA 01923
• Manufacturer Contact: derek sammarco
• MDR Report Key: 18988591
• MDR Text Key: 338732738
• Report Number: 1220648-2024-08859
• Device Sequence Number: 1
• Product Code: OZD
• UDI-Device Identifier: 00813502012279
• UDI-Public: (01)00813502012279(10)2025442536(17)250731
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PUMP SET, PUMP 381 (US)
• Device Catalogue Number: 1000080
• Device Lot Number: 2025442536
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/12/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White