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

Model Number IMPELLA CP

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problems Hemorrhage/Bleeding (1888); Thrombosis/Thrombus (4440)

Event Date 11/25/2022

Event Type  Injury  

Manufacturer Narrative

The impella device was not received from the customer.Should the device or any new information be received, a supplemental mdr will be filed.Instructions for use for the related event are as follows: ¿assess access site for bleeding and hematoma.¿ ¿remove the peel-away introducer completely from the artery over the catheter shaft to prevent trauma and significant bleeding and apply manual pressure above the puncture site.¿ ¿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" this report is being filed as part of a retrospective review of historical records.

Event Description

The user facility reported an impella cp in a 67-year-old male patient for mechanical circulatory support.It was reported that during impella support, the patient experienced excessive bleeding at the impella site.Under fluoroscopy, it was shown the catheter was kinked and there was extravasation at the site.A 8 mm x 10 cm stent was placed in the axillary artery.Penumbra device could be used to extract some of the clot that had developed at the end of the catheter, but the doctor wanted to medically manage the thrombus.

• 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: 18827708
• MDR Text Key: 336851785
• Report Number: 1220648-2024-07355
• Device Sequence Number: 1
• Product Code: OZD
• UDI-Device Identifier: 00813502011876
• UDI-Public: (01)00813502011876(10)23267603(17)240831
• 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: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0045
• Device Lot Number: 2023270046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/25/2022
• Date Manufacturer Received: 11/25/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/14/2022
• 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 Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White