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

Model Number IMPELLA CP

Device Problems Malposition of Device (2616); Difficult to Advance (2920)

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

Event Date 12/15/2023

Event Type  malfunction  

Manufacturer Narrative

The impella device was not received from the customer and therefore, an evaluation of the device was not possible.Upon investigation closure, a supplemental mdr will be filed.Instructions for use for the related event are as follows: ¿handle with care.The impella catheter can be damaged during removal from packaging, preparation, insertion, and removal.Do not bend, pull, or place excess pressure on the catheter or mechanical components at any time.¿.

Event Description

The user facility reported a 59-year-old male patient in st (sinus tachycardia) elevated myocardial infarction was implanted with an impella cp device for mechanical circulatory support.The complainant reported the patient was on impella cp support and was back in the cardiac catheterization lab.Whilst off paralytics and sedation, the patient aggressively moved and the catheter was pulled back into the aorta.The impella cp was unable to be passed back across the valve and had to be explanted.Axillary 5.5 placement is emergently planned in the cardiovascular operating room.

Manufacturer Narrative

The investigation into the positioning issues has been completed.The device was not returned for investigation.The clinical team noted that patient had aggressive movement and pump appeared to be pulled back into aorta.The root cause of the positioning issue of the pump in the aorta was due to the patient¿s excessive movement.

• Brand Name: IMPELLA CP
• Type of Device: 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
• MDR Report Key: 18477552
• MDR Text Key: 332457784
• Report Number: 1220648-2024-05960
• Device Sequence Number: 1
• Product Code: OZD
• UDI-Device Identifier: 00813502011876
• UDI-Public: (01)00813502011876(10)2024422211(17)251031
• 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,Followup
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0045
• Device Lot Number: 2024422211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2023
• 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: 59 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American