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

Model Number 0048-0003.0814

Device Problems Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964)

Patient Problem Death (1802)

Event Date 03/08/2018

Event Type  malfunction  

Event Description

The impella cp catheter failed while implanted in patient.The flow started out between 3.2 and 3.4 and then dropped to 1.2.The catheter was removed, flushed out, and re-implanted, but flow never went above 1.2.It was eventually replaced with a 2.5 l pump that was not sufficient to support the patient.A right axillary cutdown was performed and 5l pump was place.Although unrelated to the pump failure, the patient expired in the operating room.Per site reporter: (b)(4) reps were present during surgery.The device will be returned for failure analysis.

• Brand Name: IMPELLA CP
• Type of Device: TEMPORARY CARDIAC SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED, INC.; 22 cherry hill drive; danvers MA 01923
• MDR Report Key: 7356683
• MDR Text Key: 103017261
• Report Number: 7356683
• 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: Other
• Type of Report: Initial
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/31/2019
• Device Model Number: 0048-0003.0814
• Device Catalogue Number: 0048-0003
• 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: 03/15/2018
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/15/2018
• 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 Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 109