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	Hemolysis (1886); Unspecified Infection (1930); Tachycardia (2095)
Date of Event	02/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Notifications were received via abiomed¿s long-term outcome and quality indicator impella registry regarding a patient who endured respiratory failure, worsening non-sustained ventricular tachycardia, and hemolysis all with a "possible" relationship to the impella 5.5 device implanted for mechanical circulatory support.The patient was intubated after impella 5.5 placement and extubated three days later.Chest x-ray revealed that patient had pulmonary congestion which was treated with intravenous diuretics.Four days later, the patient endured worsening non-sustained ventricular tachycardia (nsvt).The patient had history of nsvt prior to the impella 5.5 implant.The patient's labs were monitored and replaced as needed and the patient continued on home amiodarone.The patient continued to have intermittent nsvt throughout this admission.Approximately two months later, the patient endured hemolysis.The patient was monitored after impella implant.However, the medical team determined lab values determined hemolysis based on lactate dehydrogenase and plasma free hemoglobin increase.The patient received a heart transplant two days later.The patient recovered with no sequelae.
Additional Manufacturer Narrative
The impella device was discarded by the customer and therefore, an evaluation of the device was not possible.Upon investigation closure, a supplemental manufacturer device report will be filed.As noted in the impella instructions for use: impella 5.5 with smartassist for use during cardiogenic shock section: table 3.2 impella catheter components ¿the infusion filter prevents bacterial contamination and air from entering the purge lumen.¿ section: warnings & cautions: warnings ¿to reduce the possibility of fibers being drawn into the impella, customers should avoid exposing the inlet and cannula section of the impella heart pumps to any surfaces or fluid baths where the device can come into contact with loose or floating fibers.¿ impella 5.5 with smartassist for use during cardiogenic shock 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 condition 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.¿.
Additional Manufacturer Narrative
The investigation for the ventricular tachycardia (vt), hemolysis, and sepsis has been completed.Product was not returned for investigation.Clinical information mentions that hemolysis was determined based of ldh and pfhgb values but no other supporting information was provided.Data logs were investigated and no motor current spikes, suction alarms or positioning issues were observed.Therefore, the root cause of the hemolysis issue was not determined since product was not returned and data log investigation was inconclusive.The root cause of the vt and sepsis could not be determined without additional 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
• MDR Report Key: 19860641
• Report Number: 1220648-2024-13480
• Device Sequence Number: 11748471
• Product Code: OZD
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 08/30/2024

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: 11/30/2025
• Device Model Number: IMPELLA 5.5
• Device Catalogue Number: 1000100
• Device Lot Number: 2024430520
• 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: 07/01/2024
• Supplement Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 07/30/2024
• Supplement Report FDA Received Date: 08/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2023
• 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: 38 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American