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 Code	Thrombosis/Thrombus (4440)
Date of Event	01/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation for the reported thrombus has been completed.The impella device was not received from the customer and therefore, an evaluation of the device was not possible.Biomaterial was observed on the pump at the time of pump removal.However, as the necessary clinical information was not provided and the device was not returned, the root cause of the thrombus could not be determined.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 was escalated to an impella ld from an impella cp for mechanical circulatory support.It was reported after the impella ld was weaned and explanted, the medical team found a clot in the graft connected to the aorta.There were no medical intervention required.

• 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: 20813698
• Report Number: 1220648-2024-24458
• Device Sequence Number: 18599599
• Product Code: OZD
• UDI-Device Identifier: 00813502011227
• UDI-Public: (01)00813502011227(10)2022136952(17)230630
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: IMPELLA LD
• Device Catalogue Number: 005082-RO
• Device Lot Number: 2022136952
• 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: 01/21/2022
• Initial Report FDA Received Date: 11/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2021
• 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: Other
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White