MAUDE Adverse Event Report: ABIOMED EUROPE GMBH IMPELLA 2.5; TEMPORARY CARDIAC SUPPORT BLOOD PUMP

Model Number IMPELLA 2.5

Device Problems Difficult to Remove (1528); Physical Resistance (2578)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/02/2017

Event Type  malfunction  

Manufacturer Narrative

The impella 2.5, 0.018" wire and clinical case were evaluated.Both the impella 2.5 and guidewire were returned with kinks.A sample impella 2.5 was used to test the ease of insertion and removal of the returned guidewire.The returned guidewire was difficult to remove from the returned pump and the sample pump.Engineering is unable to discern if the guidewire was the root cause of the issue as it was returned from the field with damage.The root cause of the guidewire interaction with the impella 2.5 was unable to be determined.A review of the device history did not reveal any nonconformities.

Event Description

A (b)(6) male patient presented to the hospital with chest pain.This patient was scheduled to have a protected percutaneous coronary intervention 5 days later.An impella 2.5 was inserted through the right femoral artery for support for hrcpi.Upon removal of the 0.018 wire during implantation of the pump, resistance was felt and the wire was unable to be removed.The impella 2.5 was pulled out of the left ventricle inadvertently, as the wire was lodged in the outlet cage, and the catheter prolapsed on itself.The device became lodged in the common femoral artery requiring surgical removal of the device.The arteriotomy was surgically closed and the patient was reported to be stable at this time.

• Brand Name: IMPELLA 2.5
• Type of Device: TEMPORARY CARDIAC SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED EUROPE GMBH; neuenhofer weg 3; aachen, 52074 ; GM 52074
• Manufacturer (Section G): ABIOMED, INC.; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: ralph barisano ; 22 cherry hill drive; danvers, MA 01923
• MDR Report Key: 6987941
• MDR Text Key: 91303719
• Report Number: 1220648-2017-00083
• Device Sequence Number: 1
• Product Code: OZD
• UDI-Device Identifier: 00813502011081
• UDI-Public: 00813502011081
• 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: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/31/2018
• Device Model Number: IMPELLA 2.5
• Device Catalogue Number: 5042
• Device Lot Number: 1276506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2017
• Was Device Evaluated by Manufacturer?: 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: 75 YR
• Patient Weight: 88