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 Codes	Hemolysis (1886); Ischemia (1942)
Date of Event	07/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Complainant reported the patient was on impella cp support due to high-risk ventricular tachycardia ablation.While on support peel away sheath deep in ventricle, groin ooze, no pulsatility, hemolyzed labs, and bloody urine was noted.Stick angle was built up and secured, and peel away sheath was repositioned; therefore, access site bleeding, and positioning issue is not reportable.Reportable due to hemolysis.
Additional Manufacturer Narrative
The impella device was not received from the customer, therefore, investigation of the device was not possible.Should the device or any new information be received, a supplemental mdr will be filed.Instructions for use for the related event are as follows: 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.¿ this report is being filed as part of a retrospective review of historical records.

• 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 ; 22 cherry hill dr.; danvers, MA 01923
• MDR Report Key: 20004079
• Report Number: 1220648-2024-15711
• Device Sequence Number: 17372204
• Product Code: OZD
• UDI-Device Identifier: 00813502011388
• UDI-Public: (01)00813502011388(10)1476557(17)220331
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 08/18/2024

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: 03/31/2022
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0032
• Device Lot Number: 1476557
• 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: 07/07/2021
• Initial Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2020
• 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: 61 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White