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

Model Number	IMPELLA LD
Medical Device Problem Codes	Positioning Failure (1158); Restricted Flow rate (1248)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/22/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
The investigation for the reported low flow and positioning issues has been completed.The impella device was not received from the customer and therefore, an evaluation of the device was not possible.However, clinical details provided were sufficient to determine a root cause.Based on the clinical account, the root cause of the low flow was improper positioning due to patient anatomy.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 pump had positioning issues which caused the pump flow to be <1.0 l/min.The physician reported issues with obtaining optimal placement of the device, and could not correct the low pump flow with repositioning.The physician decided to explant the impella ld, and replace the device with an impella 5.5.The patient underwent surgical intervention to place the impella 5.5.It was noted that the patient's care was withdrawn 11 days later and the patient expired.The positioning issues that required surgical intervention to resolve could not be excluded as a contributing factor with the limited information at hand, even though the patient expired 11 days later.

• 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: 20813695
• Report Number: 1220648-2024-24455
• Device Sequence Number: 9831082
• Product Code: OZD
• UDI-Device Identifier: 00813502011227
• UDI-Public: (01)00813502011227(10)2022119927(17)230430
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: IMPELLA LD
• Device Catalogue Number: 005082
• Device Lot Number: 2022119927
• 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: 03/22/2022
• Initial Report FDA Received Date: 11/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2021
• 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: Death
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White