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	Positioning Failure (1158)
Health Effect - Clinical Code	Sepsis (2067)
Date of Event	08/17/2021
Type of Reportable Event	Serious Injury
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) 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: use of the repositioning sheath and the 23 fr peel-aways introducer to prevent contamination and subsequent infections, always use sterile technique on the insertion site.Follow institutional protocols for prophylaxis of infection for patients on ventricular assist devices and indwelling lines, as well as protocols for surveillance of such patients.If device-related infection occurs, consider each patient¿s clinical circumstances when deciding whether to continue impella support.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.This report is being filed as part of a retrospective review of historical records.
Event or Problem Description
The complainant reported a patient in acute myocardial infarction and cardiogenic shock was implanted with an impella cp device for mechanical circulatory support.It was reported that while the patient was on impella cp support, the patient became septic.It was also reported that the impella was in the wrong position, and position could not be corrected with repositioning attempts.The medical team decided to explant the impella due to positioning issues and sepsis.The patient was successfully weaned and the impella was explanted.

• 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: 20030287
• Report Number: 1220648-2024-15540
• Device Sequence Number: 8600723
• Product Code: OZD
• UDI-Device Identifier: 00813502011388
• UDI-Public: (01)00813502011388(10)1469924(17)220331
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 08/17/2024

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: 03/31/2022
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0032
• Device Lot Number: 1469924
• 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: 08/17/2021
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2020
• 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: 55 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White