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

Model Number IMPELLA LP2.5

Device Problem Entrapment of Device (1212)

Patient Problem Perforation of Vessels (2135)

Event Date 02/12/2016

Event Type  Injury  

Manufacturer Narrative

The device was not returned for investigation; consequently a device failure evaluation could not be performed.The aic console logs were returned for analysis.The data logs provided information on the pump's performance and the patient's condition during the case.The long time logs showed that there was good patient pressure throughout the case.The normal patient pressures that were recorded for almost 2 days before the surgery make it unlikely that the ventricle was perforated during pump insertion.Cardiac tamponade symptoms can manifest in as little as 30 minutes after perforation of the ventricle wall.No symptoms were noted leading up to the procedure making it unlikely that the ventricle was perforated before the cabg began.In addition, the logs show good flow and there were no suction alarms before the surgery.If a leak was present during support, low volume would cause suction alarms to be triggered.Good flow suggests the ventricle was intact and completely sealed.It is likely that the ventricle was perforated during the surgery.The physician noted that the patient's cardiac tissue was prone to tears.The pump could have perforated the ventricle at two points during cabg.It is possible that when the pump was cross clamped it could have been moved and pushed through the wall, or it could have occurred when the physician manipulated the heart to look for targets.In conclusion, without the ability to evaluate the device in an effort to obtain additional information a definitive root cause for this event could not be determined.It is most likely that the root cause of the perforation was the friable cardiac tissue in the patient combined with manipulation of the heart during bypass with the impella in place.Device was discarded subsequent to use.

Event Description

The complainant reported that on (b)(6) 2016 a (b)(6) patient entered the facility's emergency room complaining of shortness of breath and chest pains.The patient was examined and was found to have elevated troponin levels.The patient was taken to the catheterization lab where a diagnostic catheterization was performed that revealed multi-vessel disease and weak left ventricle (lv) function.An impella lp2.5 pump was placed in the patient without issue.The patient brought to the operating room on (b)(6) 2016 for 5 coronary artery bypass grafts (cabg.) the physician performed the procedure using the "cross clamp" technique.When the doctor clamped the aorta and manipulated the heart looking for targets the catheter pigtail was seen be sticking out of the ventricle.The catheter was immediately pulled back and the physician stitched the perforation.With the repair successfully completed the doctor completed the grafts.The clamps were then removed and the impella lp2.5 was repositioned back across the valve.The physician stated that the patient had "friable tissue." when stitching the aorta he found that the tissue was thin and could be torn easily.The clinical team believed that the left ventricle perforated when the heart was manipulated during the cabg procedure or possibly during cross clamping.Following the procedure the patient was returned to the intensive care unit in stable condition.The patient had been successfully supported with the impella lp2.5 for over 67 hours when the impella lp2.5 was removed from the patient.The patient was reported to be "doing very well.".

• Brand Name: IMPELLA LP2.5
• Type of Device: IMPELLA LP2.5
• Manufacturer (Section D): ABIOMED EUROPE, GMBH (GERMANY); neuehofer weg 3; aachen, germany 13059 , GM; GM 13059, GM
• Manufacturer (Section G): ABIOMED EUROPE, GMBH (GERMANY); neuehofer weg 3; aachen, germany 13059 , GM; GM 13059, GM
• Manufacturer Contact: william bolt ; 22 cherry hill drive; danvers, MA 01923 ; 9786461451
• MDR Report Key: 5591533
• MDR Text Key: 43154806
• Report Number: 1220648-2016-00006
• Device Sequence Number: 1
• Product Code: PBL
• UDI-Device Identifier: 00813502011258
• UDI-Public: 00813502011258
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/17/2017
• Device Model Number: IMPELLA LP2.5
• Device Catalogue Number: 5042
• Device Lot Number: 1217967
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/25/2016
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2016
• Date Manufacturer Received: 03/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2015
• 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: 65 YR