MAUDE Adverse Event Report: ABIOMED, INC. IMPELLA 5.5; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Model Number IMPELLA 5.5

Device Problem Malposition of Device (2616)

Patient Problem Tachycardia (2095)

Event Date 03/02/2024

Event Type  Injury  

Event Description

The complainant from the study reported a patient on impella 5.5 support experienced tachyarrhythmia absoluta, up to 150 beats per minute on admission.Amiodarone saturation was in progress and two external electrical cardioversione (ecvs) with conversion to sinus rhythm occurred during the day.The impella had suction alarms and volume was administered.Following ecv, there were numerous polytopic ventricular extra systoles with long pauses, and then asystole.The patient had a pacemaker that was not taking over unless stimulation was given.The impella's position was checked via transesophageal echocardiogram (tee), which showed the impella was twisted and was pointing towards the septum and not the apex.The device was obstructing the opening of the mitral valve.The pump was repositioned.The events were determined to possibly be related to the device and the procedure.The impella was noted to have been successfully explanted after five days of support and the patient recovered native heart function.

Manufacturer Narrative

The impella device was discarded by the customer and therefore, an evaluation of the device was not possible.Upon investigation closure, a supplemental mdr will be filed.

• Brand Name: IMPELLA 5.5
• Type of Device: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED, INC.; 22 cherry hill dr.; danvers MA 01923
• Manufacturer (Section G): ABIOMED EUROPE GMBH; neuenhofer weg 3; aachen 52074 ; GM 52074
• Manufacturer Contact: derek sammarco ; 22 cherry hill dr.; danvers, MA 01923
• MDR Report Key: 18985262
• MDR Text Key: 338665414
• Report Number: 1220648-2024-08781
• Device Sequence Number: 1
• Product Code: OZD
• UDI-Device Identifier: 00813502013276
• UDI-Public: (01)00813502013276(10)2025454423(17)260131
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P140003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMPELLA 5.5
• Device Catalogue Number: 1000482
• Device Lot Number: 2025454423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/05/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Sex: Female
• Patient Race: White