MAUDE Adverse Event Report: ABIOMED, INC. IMPELLA 5.5; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Model Number IMPELLA 5.5

Device Problem Malposition of Device (2616)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/13/2024

Event Type  Injury  

Event Description

A 72-year-old patient fell into cardiogenic shock after an elective cardiotomy for heart valve replacement.It was decided to use the impella 5.5 smartassist heart pump for hemodynamic support.The patient was examined by computed tomography and tension was applied to the impella 5.5 patient cable during positioning on the ct table.Bleeding occurred at the axillary access site.The impella 5.5 heart pump was repositioned.The access site/anastomosis was surgically repaired to stop the bleeding.After the incident, the patient received blood transfusions (2 units of packed red cells and 3 units of blood plasma).The patient was then stable at a low level and was supported by the impella 5.5 heart pump for two more days.

Manufacturer Narrative

The impella device was not received from the customer and therefore, an evaluation of the device was not possible.Upon investigation closure, a supplemental mdr will be filed.Instructions for use for the related event are as follows: ¿assess access site for bleeding and hematoma.¿ ¿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.¿ ¿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 vascular injury.¿.

Manufacturer Narrative

The investigation into the access site bleeding ¿ major and the positioning issues has been completed since the original report was submitted.The device was not returned for investigation.The root cause of access site bleeding was most likely use related since traction was applied to the impella catheter leading to bleeding event during repositioning on ct table.Based on clinical description, the root cause of positioning issue was most likely use related.

• Brand Name: IMPELLA 5.5
• Type of Device: 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: 18822540
• MDR Text Key: 336734809
• Report Number: 1220648-2024-07297
• Device Sequence Number: 1
• Product Code: OZD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P140003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMPELLA 5.5
• Device Catalogue Number: 0550-0002
• Device Lot Number: 2024401203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male