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

Model Number IMPELLA CP EU

Device Problem Malposition of Device (2616)

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

Event Date 01/31/2024

Event Type  malfunction  

Event Description

The complainant reported patient of unknown age and gender with cardiogenic shock was put on impella cp for mechanical circulatory support following heart attack.However, pump repositioning after x-ray check, led to pump flow dropping to 0.6l.Decision was made to explant the pump and implant new impella as the patient had good pressure with catecholamines on the artery.There were no issues reported with the second pump, but patient expired because of cardiogenic shock.

Manufacturer Narrative

The impella device was received for evaluation.Upon investigation completion, 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.¿.

Manufacturer Narrative

The investigation for the reported positioning issue has been completed.The impella device has been returned for evaluation.Data logs were not returned for review.However, according to clinical details, after the pump was repositioned, the flows immediately dropped.During evaluation of the pump, visual inspection found biomaterial inside the pump housing wrapped around the impeller.Therefore, the root cause of the low pump flow was most likely due to biomaterial ingestion.The root cause of the positioning issue could not be determined as sufficient clinical details were not provided.

• Brand Name: IMPELLA CP EU
• 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 ; 22 cherry hill dr.; danvers, MA 01923
• MDR Report Key: 18740860
• MDR Text Key: 335774258
• Report Number: 1220648-2024-06889
• Device Sequence Number: 1
• Product Code: OZD
• 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,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMPELLA CP EU
• Device Catalogue Number: 0048-0014
• Device Lot Number: 2024420848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2023
• 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