MAUDE Adverse Event Report: ABIOMED EUROPE GMBH IMPELLA 2.5; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Model Number IMPELLA 2.5

Device Problems Kinked (1339); Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/07/2018

Event Type  malfunction  

Manufacturer Narrative

The returned system (of pump, wire, and introducer) was still intact.The guidewire was still inside the pump, and was in a loop within itself.The guidewire and pump were also stuck inside the introducer.The root cause of the pump's inability to cross the aortic valve was unable to be determined.The root cause of the inability to remove the guidewire, along with the pigtail kink, was the loop created by the wire.The root cause of the wire core fracture was most likely the snare used to attempt to remove the wire.There were no other complaints against this lot of pumps or guidewires.

Event Description

An impella 2.5 was placed via the right femoral to support an atherectomy patient in the cath lab.The team lost left ventricle (lv) position and so re-advanced the wire and repositioned the pump within the lv.Upon the team's attempted removal of the guidewire, the pump kinked back upon itself and the wire was unable to be removed.The team therefore attempted to remove the pump and wire in combination, but needed surgical removal techniques to be employed, as contralateral leg snaring of the product was not successful for pump and wire removal.A vessel repair/closure was done to the surgical site and the arteriotomy was closed.

• Brand Name: IMPELLA 2.5
• Type of Device: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED EUROPE GMBH; neuenhofer weg 3; aachen, 52074 ; GM 52074
• Manufacturer (Section G): ABIOMED; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: ralph barisano ; 22 cherry hill drive; danvers, MA 01923 ; 9786461400
• MDR Report Key: 7569791
• MDR Text Key: 110588116
• Report Number: 1220648-2018-00048
• Device Sequence Number: 1
• Product Code: OZD
• UDI-Device Identifier: 00813502011081
• UDI-Public: 813502011081
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/31/2020
• Device Model Number: IMPELLA 2.5
• Device Catalogue Number: 005042
• Device Lot Number: 1335495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 94 YR