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	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported a patient in acute myocardial infarction/cardiogenic shock was implanted with an impella cp device for mechanical circulatory support.It was reported that the insertion of the impella was challenging, with the pump being taken out and repositioned on 3 separate attempts.The pump was successfully implanted and the placement was verified with an echocardiogram.Survival outcome noted the patient expired.No allegations were made toward the impella cp as the cause of death.Medical safety review of the event noted use of the device cannot conclusively be associated with the outcome (patient's demise).
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.Impella cp with smartassist for use during cardiogenic shock and high-risk pci instructions for use for the related event are as follows: section: warnings & cautions: warnings ¿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 the risk of cardiac or vascular injury (including ventricular perforation).Check that the pump is positioned correctly after cpr with echocardiography guidance.¿ section: warnings & cautions: cautions never advance the guidewire or sheath when resistance is met.Determine the cause of resistance using fluoroscopy and take remedial action.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: 20032223
• Report Number: 1220648-2024-16015
• Device Sequence Number: 12389167
• Product Code: OZD
• UDI-Device Identifier: 00813502011388
• UDI-Public: (01)00813502011388(10)1435537(17)210731
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/21/2024

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: 07/31/2021
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0032
• Device Lot Number: 1435537
• 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: 07/09/2021
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2019
• 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: 60 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White