MAUDE Adverse Event Report: ABIOMED, INC. IMPELLA; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Device Problems Improper or Incorrect Procedure or Method (2017); Patient Device Interaction Problem (4001)

Patient Problem Exsanguination (1841)

Event Date 08/29/2021

Event Type  Death  

Event Description

My husband had a heart attack and was taken to hospital by ambulance.Upon arrival until 90 minutes plus he was kept in er until taken to cath lab where doctor chose to use not one but two impella devices.He did not make it.At no time did doctor confer or even tell me his spouse what was going on and only said after his demise he did all he could.Two days later receive a notice from my husbands insurance doctor wanting approval for the devices each over (b)(6).When i was taken in to see my husband they had made no attempt to clean up and there was blood every where and none of the techs would look me in the eye.I got my husbands medical records and have discovered he literally bled out from impella causing damage.I am angry upset and want this device taken off the market.If doctor would have chosen to use balloon pump my husband might still be here.He was only (b)(6) and in good health and deserved better care not based on greed.Fda safety report id# (b)(4).

Event Description

Additional information received from a reporter on 10/14/2021 for a report number mw5104432.Doctor place not one but two impellas in my husband after he suffered a major heart attack and my husband died bled out.Fda safety report id # (b)(4).

• Brand Name: IMPELLA
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): ABIOMED, INC.
• MDR Report Key: 12589612
• MDR Text Key: 275154815
• Report Number: MW5104432
• Device Sequence Number: 1
• Product Code: DWA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 10/14/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 61 YR
• Patient Weight: 75