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

Model Number IMPELLA CP

Device Problems Failure to Deliver (2338); Deformation Due to Compressive Stress (2889)

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

Event Date 07/08/2022

Event Type  malfunction  

Event Description

The user facility reported a 54-year-old male patient in acute myocardial infarction/cardiogenic shock was was being placed on an impella cp device for mechanical circulatory support.It was reported that during insertion of the impella, the healthcare staff was unable to advance the device through the patient¿s vasculature due to a kink in the cannula.The procedure was aborted.

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.This report is being filed as part of a retrospective review of historical records.

• 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 EUROPE GMBH; neuenhofer weg 3; aachen 52074 ; GM 52074
• Manufacturer Contact: derek sammarco ; 22 cherry hill dr.; danvers, MA 01923
• MDR Report Key: 18967371
• MDR Text Key: 338442084
• Report Number: 1220648-2024-08659
• Device Sequence Number: 1
• Product Code: OZD
• UDI-Device Identifier: 04260113630280
• UDI-Public: (01)04260113630280(10)2023192043(17)240331
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0014
• Device Lot Number: 2023192043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/08/2022
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/07/2022
• 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: 54 YR
• Patient Sex: Male