MAUDE Adverse Event Report: ABIOMED INC. ABIOMED; IMPELLA

Device Problems Fracture (1260); Improper Flow or Infusion (2954)

Patient Problems Cardiac Arrest (1762); Death (1802); Low Blood Pressure/ Hypotension (1914)

Event Date 08/12/2017

Event Type  Death  

Event Description

Insertion of impella cp cardiac support device was planned for protection during procedure.After obtaining access, the impella sheath was inserted, an impella cp device advanced then turned on.Position check multiple times, however, could not get decent flow (flow below 1l/min).Multiple suction arms were signaling on the device.Position appeared good, continued efforts at prepositioning the device did not change hemodynamics.The impella device was removed, placed on back table and tested in a saline solution.The device woke on level 4 with flows at 2.5 l per minute.The pigtail was readvanced ensuing it was not under papillary muscles and the impella device exchanged over the impella wire.Again a decent flow could not be obtained with a flow remaining under 1l per minute.Note the pressure was 17 to 20 mmhg on second time device loaded signifying the pt had preloaded support.The pt began to deteriorate hemodynamically fairly quickly, bp in 40s, and pt not responding to multiple vasopressors.Ejection fracture and wedge pressures verified, impella device remained in left ventricle.Stat echo-cardiogram revealed lv function deterioration with multiple wall motion abnormalities.Pt non responsive to efforts, cpr initiated.Salvage attempt to dilate ramus cx and lad, pt arrested again.Heart essentially lost all pulsatility.Team unable to resuscitated pt, who expired.

• Brand Name: ABIOMED
• Type of Device: IMPELLA
• Manufacturer (Section D): ABIOMED INC.; 22 cherry mill dr; denvers MA 01923
• MDR Report Key: 7120580
• MDR Text Key: 95067055
• Report Number: MW5073968
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 83 YR
• Patient Weight: 50