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

Model Number IMPELLA 5.5 - JP

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Date 12/29/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation into the delivery issues has been completed.No impella products were returned for evaluation.The cause of the delivery issue was most likely a catheter kink due to improper delivery technique.

Event Description

The complainant reported a patient (unknown age and gender) was implanted with an impella 5.5 device for mechanical circulatory support for unknown primary indication.The pump implant was aborted after a kink was noted following insertion and an impella cp was implanted in its stead.There was no harm to the patient.

• 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: 18963595
• MDR Text Key: 338441927
• Report Number: 1220648-2024-08639
• Device Sequence Number: 1
• Product Code: OZD
• UDI-Device Identifier: 00813502012453
• UDI-Public: (01)00813502012453(10)2023251517(17)240430
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMPELLA 5.5 - JP
• Device Catalogue Number: 1000211
• Device Lot Number: 2023251517
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/12/2023
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/21/2022
• 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 Race: Asian