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

Model Number IMPELLA CP JP

Device Problem Malposition of Device (2616)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/30/2024

Event Type  Injury  

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.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.¿ ¿potential adverse events (united states) acute renal dysfunction, aortic valve injury, bleeding, cardiogenic shock, cerebral vascular accident/stroke, death, hemolysis, limb ischemia, myocardial infarction, renal failure, thrombocytopenia and vascular injury.¿.

Event Description

The complainant reported that the 79-year-old male patient was scheduled to undergo coronary artery bypass graft (cabg) under impella support.The impella cp was inserted in the catheterization room, and the patient was transferred to the operating room.Echocardiography was performed in the operating room and found a large amount of mitral regurgitation (mr).The impella position was confirmed but it was found that it had been inserted in the direction of the mitral valve.It was determined that the mr had increased due to the problem with the impella position.Attempts were made to adjust the impella's position, but it either pulled out or entered the direction of the m valve, making it difficult to adjust.Impella was removed and cabg continued.

Manufacturer Narrative

The investigation into the positioning issues has been completed since the initial report was submitted.The device was not returned for investigation.The cause of the positioning issue was due to patient condition related with pump unable to reposition due to mitral regurgitation.

• Brand Name: IMPELLA CP JP
• 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: 18741232
• MDR Text Key: 335810288
• Report Number: 1220648-2024-06901
• Device Sequence Number: 1
• Product Code: OZD
• 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: 02/20/2024

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?: Yes
• 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: 2024428551
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/12/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian