MAUDE Adverse Event Report: ABIOMED IMPELLA CP

Model Number 0042-0020

Device Problems Pumping Stopped (1503); Device Inoperable (1663)

Patient Problem Death (1802)

Event Date 02/09/2014

Event Type  Death  

Event Description

Abiomed impella device failed; pump stopped and patient arrested resulting in death on (b)(6) 2014.

• Brand Name: IMPELLA CP
• Type of Device: IMPELLA CP
• Manufacturer (Section D): ABIOMED
• MDR Report Key: 3639359
• MDR Text Key: 4206616
• Report Number: MW5034565
• Device Sequence Number: 1
• Product Code: KFM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0042-0020
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PLACEMENT OF IMPELLA CP; PLACEMENT OF IABP; MANUAL THROMBECTOMY WITH FETCH CATHETER MID,; MECHANICAL THROMBECTOMY WITH ANGIOJET OF LCX OM3; PCI (BARE METAL STENT) OF MID LAD AND LCX OM3; RIGHT HEART CATHETER; REMOVAL OF TEMP PACER; PLACEMENT OF TEMP PACER; REMOVAL OF IABP; LAD/ DIAG/ LCX
• Patient Outcome(s): Death; Life Threatening; Required Intervention
• Patient Age: 40 YR
• Patient Weight: 77