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

Model Number	IMPELLA LD
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Thrombosis/Thrombus (4440)
Date of Event	07/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The impella device was not received from the customer, therefore, investigation of the device was not possible.Should the device or any new information be received, a supplemental mdr will be filed.This report is being filed as part of a retrospective review of historical records.
Event or Problem Description
The complainant reported a patient in post cardiotomy cardiogenic shock and with low cardiac output syndrome was implanted with an impella ld for mechanical circulatory support.It was reported while on impella ld support, the patient was taken to the or for exploratory surgery.The patient had significant oozing from root and at valve and had cardiac tamponade and the left ventricle was being compressed.A large clot was removed, and 1500ml of volume was removed from the chest.The patient was transfused with 2 cell saver, 1 unit of packed red blood cells, and 1 unit of platelets.The patient had been heparinized for impella use, heparin was discontinued.The patient remained on impella ld support following the intervention until the patient was successfully weaned and explanted.

• Brand Name: IMPELLA LD
• Common Device Name: 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: 20813679
• Report Number: 1220648-2024-24451
• Device Sequence Number: 9830576
• Product Code: OZD
• UDI-Device Identifier: 00813502011227
• UDI-Public: (01)00813502011227(10)2022070993(17)230331
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 03/31/2023
• Device Model Number: IMPELLA LD
• Device Catalogue Number: 005082-RO
• Device Lot Number: 2022070993
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 11/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White