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

Model Number IMPELLA 5.5 - EU

Device Problems Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981)

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

Event Date 03/14/2024

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.

Event Description

The complainant reported a patient (race unknown) post cardiotomy cardiogenic shock / low cardiac output syndrome was implanted with an impella 5.5 for mechanical circulatory support.During implant, the cannula kinked after several attempts to get the pump over a narrow area at the transition from the axial artery to the brachial artery.The pump was not removed as the kink in the cannula did not impact patient support.

• Brand Name: IMPELLA 5.5
• 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: 18997630
• MDR Text Key: 338881865
• Report Number: 1220648-2024-08893
• Device Sequence Number: 1
• Product Code: OZD
• UDI-Device Identifier: 00813502011630
• UDI-Public: (01)00813502011630(10)2025447615(17)251231
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMPELLA 5.5 - EU
• Device Catalogue Number: 0550-0002
• Device Lot Number: 2025447615
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/14/2024
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/23/2023
• 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: 75 YR
• Patient Sex: Male