MAUDE Adverse Event Report: ABIOMED, INC. IMPELLA CP; TEMPORARY CARDIAC SUPPORT BLOOD PUMP

Model Number IMPELLA CP

Device Problems Pumping Stopped (1503); Device Issue (2379)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 10/03/2017

Event Type  malfunction  

Manufacturer Narrative

The returned impella cp, aic console data and case data was evaluated.The console data revealed the purge pressure begins to rise to above 1000 mmhg 36 hours into the case (about 2x the normal value).The console data logs show the case began at 11 pm on october 1st; and show the system was changed to standard configuration at 11:45 pm.According to the salesforce database, at 9:18 am the following morning the abiomed clinical support center (csc) received a call regarding high purge pressure, at which point the csc representative realized that 5% dextrose in lactated ringer's solution was in the purge system.The representative instructed the clinical staff to change the purge fluid immediately.During the time between 9:30 am and 12:00 pm, there were three purge fluid changes and one purge cassette change, however the purge pressure remained high.The data logs also reveal the pump stopped due to high motor current at 1:30 pm.Post-case inspection of the pump revealed an accumulation of some type of gelatinous amber material in the gap between the impeller and sleeve bearing of the motor, which is where the purge fluid exits.The root cause of the high purge pressure is the buildup found in the motor.The pump most likely stopped due to the material that was accumulating in the gap between the impeller and sleeve bearing, causing higher friction on the impeller shaft until the pump exceeded its current rating and shut off.The most likely cause of the buildup is use of the 5% dextrose in lactated ringer's solution in the purge system.This solution contains multiple additives that likely can cause a reaction with the pump leading to the accumulation that was found in the motor.The impella cp ifu recommends using dextrose in water as a purge solution.(b)(4).

Event Description

(b)(6) year old male patient presented to the er with a st-elevation myocardial infarction (stemi), coded, was intubated, and was brought to the cardiac catheterization laboratory (ccl).A temporary pacer was placed as well as an impella cp as a last ditch effort.The impella cp was inserted through the right femoral artery and support was initiated.Left heart catheterization revealed 100% occlusion of the left anterior descending artery and 90% occlusion of the circumflex artery.Intervention was performed and the patient was sent to icu, where the impella catheter system was switched to standard configuration.The following day, the impella cp purge pressure and motor current increased and during a call with the abiomed clinical support center it was discovered that 5% dextrose in lactated ringer's solution was used as the purge solution initially during the case instead of 5% dextrose in water.Lactated ringer's solution contains additives such as sodium, calcium, lactate, potassium and chloride that are damaging to the pump.The impella cp ifu recommends using dextrose dw solution in the purge system, and warns the user against using saline in the purge system.The purge solution was exchanged from 5% dextrose in lactated ringer's solution to 5% dextrose solution, however the purge pressure and motor current continued to rise.The patient was continuing to decompensate while the clinical team made plans to exchange the pump.The pump stopped and the patient expired while the pump exchange was being prepared.

Manufacturer Narrative

The user medwatch report received by abiomed included the patient age, which has been added to this follow up report.The user medwatch report listed the device serial number as (b)(4), however the serial number is (b)(4).17-0929 follow up :user mdr from fda mw # (b)(4).

Event Description

A user medwatch report received by abiomed.There is corrected information included.The original age listed in initial report is (b)(6), however the corrected patient age in this report is (b)(6).

• Brand Name: IMPELLA CP
• Type of Device: TEMPORARY CARDIAC SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED, INC.; 22 cherry hill drive; danvers MA 01923
• 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: 6989261
• MDR Text Key: 90628802
• Report Number: 1220648-2017-00098
• Device Sequence Number: 1
• Product Code: OZD
• UDI-Device Identifier: 00813502011258
• UDI-Public: 00813502011258
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P1400003
• 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,Followup
• Report Date: 10/03/2017

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: 07/31/2019
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0003
• Device Lot Number: 1301925
• 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: 10/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2017
• 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: 56 YR