MAUDE Adverse Event Report: ABIOMED, INC. IMPELLA 5.5; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Model Number	IMPELLA 5.5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Hemothorax (1896); Pleural Effusion (2010); Ventricular Fibrillation (2130); Cardiac Tamponade (2226); Thrombosis/Thrombus (4440); Intraoperative Cardiac Injury (4855)
Date of Event	04/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via the impact eu study a patient experienced a mediastinal hemorrhage with a definite relationship to impella device.The adverse event narrative explained the patient was going to be discharged the day of the event (which was four days after explant of the impella 5.5 device; the patient recovered to native heart function).The patient was unresponsive after the second walk to the room on the unit.The patient's pulse dropped, and code blue was activated.Cardiopulmonary was administered and return of spontaneous circulation achieved.There was a significant growing left pleural effusion.Left chest tube was placed with return of 1500ml of blood.The patient received 4 units of packed red blood cells, 1 fresh frozen plasma and 1 platelet.Arterial blood gas revealed acidosis, 4 amps.Bicarbonate was given.The patient was taken to the operating room for mediastinal washout.Small bleeding from the side of the right coronary button was found and stitch was placed.The patient was noted to have survived the event.
Additional Manufacturer Narrative
The impella device was not received from the customer and therefore, an evaluation of the device was not possible.Upon investigation closure, a supplemental mdr will be filed.
Additional Manufacturer Narrative
The investigation of vascular damage - great vessel has been completed.Patient had 5.5 implanted and explanted without issue, with successful weaned from support.Four days after explant, patient experienced mediastinal hemorrhage.During or intervention for mediastinal washout, with small bleeding from the side of the right coronary button.No product returned.Data logs returned but not applicable to this failure mode.The cause of the vascular damage - great vessel was not determined since product was not returned and lack of clinical details.E4 should have been left blank on the initial manufacturer device report number 1220648-2025-26215 is it is unknown if the initial reporter also sent the report to the food and drug administration.
Event or Problem Description
Additionally, the patient experienced ventricular fibrillation during code on (b)(6) 2024, leading to cardiac arrest.Around 12:45, patient was walking, felt light-headed, had pre-syncope, became hypotensive, and code blue was called due to suspected cardiac arrest.12:53, second code blue called, patient unresponsive, pea noted on monitor.Cpr started.Ns 1000 ml free flow started, levo drip started, patient intubated, central and arterial lines placed.Echo and tee done.13:02; rosc achieved, cpr stopped.Amiodarone started at 1 mg and discontinued coreg.The patient had a large left hemothorax noted.The patient underwent emergency mediastinal re-exploration.Tee was used to diagnose the presence of tamponade, evacuation of clots, and changes in ventricular or valvular function during the surgery.During the procedure, the patient had a repair of the aortic hole with a pericardial patch and chest tube for hemothorax.Per the principal investigator (pi), cardiac arrest with the ventricular fibrillation possible related to the impella procedure and the impella device.The left hemothorax(bleeding) definite related to the impella device and the impella procedure.
Additional Manufacturer Narrative
The investigation of vf/vt/af/at and access site bleeding has been completed.The impella device was not returned for evaluation.Vf/vt/af/at: the root cause of the vt/vf/at/af was unable to be determined due to insufficient clinical details.Access site bleeding: the cause of the access site bleeding - major was not determined since product was not returned and insufficient clinical details.

• Brand Name: IMPELLA 5.5
• 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: 21420301
• Report Number: 1220648-2025-26215
• Device Sequence Number: 15373642
• Product Code: OZD
• UDI-Device Identifier: 00813502011531
• UDI-Public: (01)00813502011531(10)2024305879(17)241231
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/08/2025

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: 12/31/2024
• Device Model Number: IMPELLA 5.5
• Device Catalogue Number: 0550-0008
• Device Lot Number: 2024305879
• 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: 01/28/2025
• Supplement Date Received by Manufacturer: 03/12/2025; 07/14/2025; 08/27/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 03/17/2025; 07/29/2025; 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2023
• 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; Life Threatening
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White