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

Model Number IMPELLA 5.5

Device Problems Malposition of Device (2616); Material Twisted/Bent (2981)

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

Event Date 05/11/2022

Event Type  malfunction  

Event Description

The user facility reported a 69-year-old male undergoing cardiac surgery was implanted with an impella 5.5 device for mechanical circulatory support.The complainant reported that complications were encountered during implant of of an impella 5.5 pump.When advanced into place, the.018" guidewire was seen under echocardiogram (echo) to be located under the papillary muscle.The decision was made to remove the pump and guidewire for re-insertion; however, the guidewire was found to be kinked.The wire was swapped and the pump was implanted without further issue.After implant, some oozing was noted at the axillary access site, but intervention was not required.There was no patient harm and support with the implanted pump continued as planned.

Manufacturer Narrative

The impella device was discarded by 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 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: 17860317
• MDR Text Key: 324791566
• Report Number: 1220648-2023-03584
• Device Sequence Number: 1
• Product Code: OZD
• UDI-Device Identifier: 00813502011531
• UDI-Public: (01)00813502011531(10)2023194837(17)240229
• 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: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: IMPELLA 5.5
• Device Catalogue Number: 0550-0008
• Device Lot Number: 2023194837
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/11/2022
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/15/2022
• 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: 69 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White