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

Model Number	IMPELLA RP
Medical Device Problem Codes	Failure to Advance (2524); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hemodynamic instability (4868)
Date of Event	12/15/2021
Type of Reportable Event	Death
Event or Problem Description
The complainant reported a patient with cardiomyopathy was implanted with an impella rp for mechanical circulatory support.Multiple rp catheters kinked during insertion and failed delivery.The procedure outcome is the patient passed away and there is not enough information to exclude the impella device as an associated factor in the patient's demise.
Additional Manufacturer Narrative
The returned pump was visually inspected and multiple kinks in the catheter were confirmed.The root cause of the reported delivery issues was determined to be the observed catheter kinks.Refer to es2020-080 for further information.Based on the provided information, the catheter kinks were most likely caused by excessive force during pump insertion.As noted in the impella ifu: impella rp smartassist system with automated impella controller section: warnings & cautions: warnings section: pre-support evaluation section: axillary insertion of the impella 5.5 catheter section: direct aortic insertion section: use of impella with transcatheter aortic valves ¿to reduce the risk of cardiac or vascular injury (including ventricular perforation) physicians should exercise special care when inserting the impella catheter in patients with complex anatomy.This includes patients with known or suspected: decreased ventricular cavity size, ventricular aneurysms, thin-walled ventricles due to chronic dilation, congenital heart disease, or compromised cardiac tissue quality.¿ ¿to reduce the risk of cardiac or vascular injury (including ventricular perforation) when advancing or torquing the impella, adjustments should be performed under imaging guidance.¿ section: warnings & cautions: warnings ¿physicians should exercise special care when inserting the impella catheter during active cardiopulmonary resuscitation (cpr).In addition, active cpr maneuvers may change the position of the impella device, introducing the risk of cardiac or vascular injury (including ventricular perforation).Check that the pump is positioned correctly after cpr with chest x-ray guidance.¿ section: warnings & cautions: cautions ¿dilators and catheters should be removed slowly from the sheath.Rapid removal may damage the valve, resulting in blood flow through the valve.¿ section: warnings & cautions: warnings ¿to reduce the risk of cardiac or vascular injury (including perforation) when manipulating the heart during cardiac surgery, evaluate the position of the pump using imaging guidance prior to manipulating the heart, and monitor position.¿ ¿to reduce the risk of cardiac or vascular injury (including perforation) when manipulating the heart during cardiac surgery, evaluate the position of the pump using imaging guidance.¿ section: warnings & cautions: warnings section: pre-support evaluation section: axillary insertion of the impella 5.5 catheter section: direct aortic insertion section: use of impella with transcatheter aortic valves ¿to reduce the risk of cardiac injury (including ventricular perforation), physicians should exercise special care when inserting the impella catheter in patients with complex anatomy.This includes patients with known or suspected decreased ventricular cavity size, ventricular aneurysms, congenital heart disease, or compromised cardiac tissue quality in the settings of acute infarction with tissue necrosis.¿ ¿to reduce the risk of vascular injury, physicians should exercise caution when inserting the impella catheter in patients with complex peripheral vascular anatomy.This includes patients with known or suspected: unrepaired abdominal aortic aneurysm, significant descending thoracic aortic aneurysm, dissection of the ascending/ transverse/descending aorta, chronic anatomical changes in the relationship of the aorta/aortic valve/ventricular alignment, significant mobile atheromatous disease in the thoracic or abdominal aorta or peripheral vessels.¿ ¿physicians should exercise special care when inserting the impella catheter during active cardiopulmonary resuscitation (cpr).In addition, active cpr maneuvers may change the position of the impella device, introducing a risk of cardiac or vascular injury (including ventricular perforation).Check that the pump is positioned correctly in the left ventricle after cpr with echocardiography guidance.Section: potential adverse events (united states) ¿arrhythmia, atrial fibrillation, bleeding, cardiac tamponade, cardiogenic shock, death, device malfunction, hemolysis, hepatic failure, insertion site infection, perforation, phlegmasia cerulea dolens (a severe form of deep venous thrombosis), pulmonary valve insufficiency, respiratory dysfunction, sepsis, thrombocytopenia, thrombotic vascular (non-central nervous system complication, tricuspid valve injury, cardiac or vascular injury (including ventricular perforation), venous thrombosis, ventricular fibrillation and/or tachycardia.¿ section: warnings & cautions: warnings ¿do not advance or withdraw the impella rp flex with smartassist system catheter against resistance without using fluoroscopy to determine the cause of the resistance.Doing so could result in separation of the catheter or guidewire tip, damage to the catheter or vessel, or perforation.¿ section: warnings & cautions: warnings section: pre-support evaluation section: axillary insertion of the impella 5.5 catheter section: direct aortic insertion section: use of impella with transcatheter aortic valves ¿to reduce the risk of cardiac or vascular injury (including perforation) when manipulating the heart during cardiac surgery, evaluate the position of the pump using imaging guidance prior to manipulating the heart, and monitor position.¿ ¿to reduce the risk of cardiac or vascular injury (including ventricular perforation) physicians should exercise special care when inserting the impella catheter in patients with complex anatomy.This includes patients with known or suspected: decreased ventricular cavity size, ventricular aneurysms, thin-walled ventricles due to chronic dilation, congenital heart disease, or compromised cardiac tissue quality.¿ ¿to reduce the risk of cardiac or vascular injury (including ventricular perforation) when advancing or torquing the impella, adjustments should be performed under imaging guidance.¿ section: warnings & cautions: warnings ¿physicians should exercise special care when inserting the impella catheter during active cardiopulmonary resuscitation (cpr).In addition, active cpr maneuvers may change the position of the impella device, introducing the risk of cardiac or vascular injury (including ventricular perforation).Check that the pump is positioned correctly after cpr with chest x-ray guidance.¿.

• Brand Name: IMPELLA RP
• Common Device Name: TEMPORARY NON-ROLLER TYPE RIGHT 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: 20575366
• Report Number: 1220648-2024-21610
• Device Sequence Number: 15597180
• Product Code: PYX
• UDI-Device Identifier: 00813502011029
• UDI-Public: (01)00813502011029(10)1468332(17)220131
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P170011
• 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): 10/30/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: IMPELLA RP
• Device Catalogue Number: 004334
• Device Lot Number: 1468332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Death
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White