IMPELLA CP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-08 for IMPELLA CP manufactured by Abiomed, Inc..

Event Text Entries

[137050815] Patient requiring mechanical circulatory support via an impella cp. On (b)(6) 2019 the patient? S impella device stopped functioning while the patient was in intensive care unit requiring emergent surgery. (b)(6) female with cad, type 2 diabetes and history of myocardial infarction and cabg. Patient was admitted on (b)(6) 2018 due to worsening cardiac and respiratory symptoms. Due to her low cardiac output and severe left ventricular systolic failure it was decided that she would be a candidate for mechanical circulatory support. On (b)(6) 2019 she underwent placement of the impella cp. The impella cp was positioned without complication trans-aortic into the left ventricle and left ventricular support was initiated. On (b)(6) 2019 it was discovered that the impella cp had an acute malfunction in the intensive care unit with complete stoppage of the pump and inability to restart the pump. The patient was taken immediately to the hybrid room for impella removal and replacement. On arrival to the hybrid room the patient became unstable and went into pea arrest. The patient was placed on cardiopulmonary bypass. The impella was removed. Another impella was placed. There was multiple attempts to wean the patient from cardiopulmonary bypass with temporary periods of stability followed by worsening respiratory response. The patient was transitioned from cardiopulmonary bypass to ecmo. The patient was transferred on va ecmo support, impella support to the intensive care unit in stable condition. The impella was picked up by representatives of abiomed for interrogation of the device to determine the cause of the malfunction.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 8361320
• MDR Report Key: 8361320
• Date Received: 2019-02-08
• Date of Report: 2019-01-31
• Date of Event: 2019-01-18
• Date Facility Aware: 2019-01-21
• Report Date: 2019-01-31
• Date Reported to FDA: 2019-02-01
• Date Reported to Mfgr: 2019-01-31
• Date Added to Maude: 2019-02-22
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: IMPELLA CP
• Generic Name: MECHANICAL CIRCULATORY SUPPORT DEVICE
• Product Code: PBL
• Date Received: 2019-02-08
• Returned To Mfg: 2019-01-18
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ABIOMED, INC.
• Manufacturer Address: DANVERS MA US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening; 2. Required No Informationntervention	2019-02-08