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

Model Number	IMPELLA RP US PUMP SET
Medical Device Problem Codes	Failure to Advance (2524); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was returned: - the cause of the failure mode was patient condition related.Instructions for use for the related event are as follows: 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.
Event or Problem Description
The complainant reported a failed rp delivery.Support with this device was aborted.There was no harm to the patient resulting from this issue.

• 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 ; 22 cherry hill dr.; danvers, MA 01923
• MDR Report Key: 20575635
• Report Number: 1220648-2024-21627
• Device Sequence Number: 8575347
• Product Code: PYX
• UDI-Device Identifier: 00813502011029
• UDI-Public: (01)00813502011029(10)2022081523(17)230331
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P170011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: IMPELLA RP US PUMP SET
• Device Catalogue Number: 004334
• Device Lot Number: 2022081523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2022
• Initial Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2021
• 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
• Patient Age: 37 YR
• Patient Sex: Male