MAUDE Adverse Event Report: ABIOMED EUROPE, GMBH (GERMANY) IMPELLA RECOVER LP2.5 PERC CARDIAC SUPPORT

Model Number LP2.5

Device Problems Device Stops Intermittently (1599); Device Inoperable (1663)

Patient Problems Chest Pain (1776); Death (1802); Respiratory Distress (2045)

Event Date 08/19/2014

Event Type  Death  

Event Description

The complainant reported that a (b)(6) yr old male pt was admitted to the hosp through the emergency room.The pt presented with chest pains and shortness of breath.The cardiac catheterization laboratory (ccl) placed stents in the left main artery and the left anterior descending artery.Following the revascularization, the pt started to crash, resulting in the placement of an internal aortic balloon pump (iabp).The pt was then air lifted to this facility where the staff decided to remove the iabp and place an impella lp2.5 pump.The impella was prepped and inserted into the left ventricle.The impella was started and but then stopped several times.The team then began to remove the device in preparation for inspection and to then reinsert into the pt, but the pt expired, prior to completing this process.

Manufacturer Narrative

The motor power control (mpc) console data logs were reviewed.The review of the logs revealed that the start of the case was completed normally and the pump was successfully placed in the pt.As was reported, multiple attempts to start the impella were unsuccessful.Based upon the data log review, the impella was never able to be started.A physical examination of the returned impella lp2.5 pump revealed a severe kink in the steering catheter just proximal to the catheter-motor junction.In addition, the outflow cage was significantly deformed, resulting in contact between the impeller motor and pump housing this contact prevented the impeller from rotating.During the eval, the outflow cage was straightened which allowed the impeller to rotate freely.The pump then operated normally in a functional bench test.In conclusion, the cause of the reported issue was the result of damage to the cage which most likely occurred during implantation of the pump.There was a shark kink in the steering catheter, just proximal to the motor housing, indicating that the pump saw high forces during insertion.The root cause of this event has been determined to be excessive force exerted by the user during device placement.Internal (b)(4).

• Brand Name: IMPELLA RECOVER LP2.5 PERC CARDIAC SUPPORT
• Manufacturer (Section D): ABIOMED EUROPE, GMBH (GERMANY); aachen ; GM
• Manufacturer Contact: william bolt ; 22 cherry hill dr.; danvers, MA 01923 ; 9786461451
• MDR Report Key: 4115810
• MDR Text Key: 4940013
• Report Number: 1220648-2014-00007
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2016
• Device Model Number: LP2.5
• Device Catalogue Number: 0046-3061
• Device Lot Number: 88772
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/24/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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): Death
• Patient Age: 58 YR