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	Increase in Pressure (1491)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint has been identified as part of a retrospective review.Due to the limited clinical information and lack of available data/product the root cause of this investigation is not 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 that a patient in acute myocardial infarction/cardiogenic shock was implanted with an impella ld device for mechanical circulatory support as a bridge to therapy.While on support, the patient experienced bleeding issues during the coronary artery bypass graft requiring six units of packed red blood cells, 6 units of fresh frozen plasma, and two units of platelets.It was reported that due to high purge pressure issues that tissue plasminogen activator was started resulting in a cleared purge pathway.The patient remained on impella support and was reported to have survived a successful weaning and explant.

• 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 ; 22 cherry hill dr.; danvers, MA
• MDR Report Key: 20810476
• Report Number: 1220648-2024-24346
• Device Sequence Number: 9254406
• Product Code: OZD
• UDI-Device Identifier: 00813502011227
• UDI-Public: (01)00813502011227(10)1483644(17)220630
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 2021
• 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): 11/29/2024

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: 06/30/2022
• Device Model Number: IMPELLA LD
• Device Catalogue Number: 005082-RO
• Device Lot Number: 1483644
• 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: 05/31/2021
• Initial Report FDA Received Date: 11/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2020
• 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: 43 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic