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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A.5 race is unknown.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 manufacturer device report will be filed.As noted in the impella instructions for use: impella cp with smart assist system section: general patient care considerations ¿assess access site for bleeding and hematoma.¿ section: entering cardiac output use of the repositioning sheath and peel-away introducer ¿remove the peel-away introducer completely from the artery over the catheter shaft to prevent trauma and significant bleeding and apply manual pressure above the puncture site.¿ 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).¿ 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/cardiogenic shock was implanted with an impella cp device for mechanical circulatory support.It was reported while on impella cp support, the patient experienced bleeding at the impella insertion site.The perclose sutures were tightened down and hemostasis was achieved.It was noted that the patient expired while on support.Medical safety review of the event noted the use of the device cannot conclusively be associated with the outcome (patient's demise).

• 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
• Manufacturer (Section G): ABIOMED, INC.; 22 cherry hill dr; danvers MA 01923
• Manufacturer Contact: derek sammarco
• MDR Report Key: 20060330
• Report Number: 1220648-2024-16543
• Device Sequence Number: 15618797
• Product Code: OZD
• UDI-Device Identifier: 00813502011388
• UDI-Public: (01)00813502011388(10)1410920(17)210228
• 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: 2019
• Device Explanted Year: 2019
• 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): 08/25/2024

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: 02/28/2021
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0032
• Device Lot Number: 1410920
• 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: 05/21/2019
• Initial Report FDA Received Date: 08/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 89 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic