MAUDE Adverse Event Report: ABIOMED, INC. IMPELLA 2.5; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Model Number	IMPELLA 2.5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The complainant reported a patient noted as high risk percutaneous coronary intervention was implanted with an impella 2.5 device for mechanical circulatory support.It was reported after the impella 2.5 was successfully weaned and explanted, there was difficulty tightening the perclose device to close the impella access site.The access site was oozing after perclose deployment, aso angioseal was also deployed to achieve hemostasis.
Additional Manufacturer Narrative
The investigation for the reported access site bleeding issue 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.The root cause of the access site bleeding issue was most likely use related, as after explant there was difficulty tightening percloses as per the clinical description provided.This report is being filed as part of a retrospective review of historical records.

• Brand Name: IMPELLA 2.5
• 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 01923
• MDR Report Key: 20730242
• Report Number: 1220648-2024-23563
• Device Sequence Number: 18218831
• Product Code: OZD
• UDI-Device Identifier: 00813502011081
• UDI-Public: (01)00813502011081(10)2022043202(17)221130
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 11/19/2024

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: 11/30/2022
• Device Model Number: IMPELLA 2.5
• Device Catalogue Number: 005042-RO
• Device Lot Number: 2022043202
• 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: 04/05/2021
• Initial Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2021
• 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: 70 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White