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

Model Number IMPELLA CP - JP

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Date 04/13/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation into the delivery issues has been completed.The impella product was not returned for review.Based on clinical description, the root cause of delivery issue was most likely due to patient condition of diseased vessels.

Event Description

The complainant reported a patient (unknown age and gender) undergoing cardiac surgery was implanted with an impella cp device for mechanical circulatory support.Upon the initial delivery attempt, it was noted that the pump failed to advance in the iliac due to stenosis.A second attempt was made from below the collarbone and it was observed that the shaft of the catheter had kinked.The pump was replaced as a result of the noted damage.The device was discarded.There was no patient harm.

• 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, INC.; 22 cherry hill dr.; danvers MA 01923
• Manufacturer Contact: derek sammarco
• MDR Report Key: 18963662
• MDR Text Key: 338549493
• Report Number: 1220648-2024-08640
• Device Sequence Number: 1
• Product Code: OZD
• UDI-Device Identifier: 00813502011609
• UDI-Public: (01)00813502011609(10)2023256201(17)240831
• 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 CP - JP
• Device Catalogue Number: 0048-0024-JP
• Device Lot Number: 2023256201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/14/2023
• Date Manufacturer Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/06/2022
• 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 Ethnicity: Non Hispanic
• Patient Race: Asian