MAUDE Adverse Event Report: ABIOMED, INC. IMPELLA CP; PUMP, CATHETER BASED

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Death (1802)

Event Date 05/31/2016

Event Type  malfunction  

Event Description

This middle-aged male patient arrived to the cath lab for a left heart catheterization, coronary angiography and a left ventriculogram.The patient was transferred from the cath lab to the main or for an emergent cardiac salvage coronary artery bypass x 3.The patient arrived to the operating room with an impella pump.However, during the case, the impella pump did not register like it did in the beginning of the case.There was a question about whether or the impella pump was working correctly.The surgeon then placed a balloon pump in the patient.The patient subsequently expired during the surgery.It is unknown at this time if this event contributed to the patient's outcome.The rep for a biomed was present during the procedure.

• Brand Name: IMPELLA CP
• Type of Device: PUMP, CATHETER BASED
• Manufacturer (Section D): ABIOMED, INC.; 22 cherry hill drive; danvers MA 01923
• MDR Report Key: 5705333
• MDR Text Key: 46818471
• Report Number: 5705333
• Device Sequence Number: 1
• Product Code: PBL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Other Device ID Number: 4124615077947
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/06/2016
• Event Location: Hospital
• Date Report to Manufacturer: 06/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 51 YR