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

Model Number	IMPELLA CP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemolysis (1886)
Date of Event	08/07/2015
Type of Reportable Event	Malfunction
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.Instructions for use for the related event are as follows: impella cp with smartassist system.Section: potential adverse events (united states).¿acute renal dysfunction, aortic valve injury, bleeding, cardiogenic shock, cerebral vascular accident/stroke, death, hemolysis, limb ischemia, myocardial infarction, renal failure, thrombocytopenia and cardiac or vascular injury (including ventricular perforation).¿ section: use of echocardiography for positioning of the impella catheter ¿evaluate the position of the impella catheter if the automated impella controller displays position alarms or if you observe lower than expected flows or signs of hemolysis.If the catheter does not appear to be correctly positioned, initiate steps to reposition it.¿ impella catheter too far into the left ventricle ¿obstruction of the impella catheter inlet area can lead to increased mechanical forces on blood cell walls and subsequent hemolysis, which often presents as dark or blood colored urine.¿ section: hemolysis: ¿hemolysis should be monitored during support.Patients who develop high levels of hemolysis may show signs of decreased hemoglobin levels, dark or blood-colored urine, and in some cases, acute renal failure.Plasma-free hemoglobin (pfhgb) is the best indicator to confirm whether a patient is exposed to an unacceptable level of hemolysis¿ ¿patient conditions¿ including catheter position, pre-existing medical conditions, and small left ventricular volumes¿ may also play a role in patient susceptibility to hemolysis.¿ section: suction ¿suction may occur if the blood volume available for the impella catheter is inadequate or restricted.Suction limits the amount of support that the impella catheter can provide to the patient and results in a decrease in arterial pressure and cardiac output.It can damage blood cells, leading to hemolysis.It may also be an indicator of right heart failure.¿.
Event or Problem Description
A publication entitled: ¿severe mitral regurgitation and biventricular heart failure successfully treated with biventricular percutaneous axial flow pumps as a bridge to mitral valve surgery" reported a 61-year-old male of unknown ethnicity in which a bipella rp-cp support was used.The impella cp was explanted for hemolysis, and replaced by intra-aortic balloon pump (iabp).Support was proceeded with the impella rp.
Additional Manufacturer Narrative
The investigation into the hemolysis issue has been completed since the original report was submitted.The device was not returned for investigation.Therefore, the root cause of the hemolysis issue was not determined since product was not returned, data logs were not returned, and insufficient clinical information was provided.

• Brand Name: IMPELLA CP
• 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: 19313862
• Report Number: 1220648-2024-11171
• Device Sequence Number: 19602139
• Product Code: OZD
• UDI-Device Identifier: 00813502011258
• UDI-Public: (01)00813502011258(10)1190507(17)170331
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024

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: 03/31/2017
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0003
• Device Lot Number: 1190507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/02/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: IMPELLA RP
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Race: White