MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP; VENTRICULAR (ASSIST) BYPASS

Device Problems Failure to Pump (1502); Vibration (1674); Pumping Problem (3016); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/31/2020

Event Type  Injury  

Manufacturer Narrative

This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation and destination therapy in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings.Additional products: brand name: heartware ventricular assist system ¿ controller, model #: unk/ catalog #: unk / expiration date: unk / serial or lot#: unk, udi #:asku, device available for evaluation: no, device mfg date: unk, labeled for single use: no, (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the controller driveline port was loose and lost it's seal.The controller was exchanged and the ventricular assist device (vad) would not restart, and cycled through 800 revolutions per minute and a high power of 28 watts.The vad was heard to be chugging while attempting to restart and the patient could feel vibrations.The patient was exchanged back to the original controller, the vad did not restart, and a controller fault alarm occurred.The controller was exchanged again and continued to cycle inappropriately.Health care professionals discontinued vad support and the patient was transferred to the catheter lab and reactivated on the transplant list.The patient was transplanted the next day.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

A supplemental is being submitted for investigation completion.Product event summary: one (1) hvad pump of unknown serial number and one (1) controller of unknown serial number were not returned for evaluation.Review of the controller log files was not performed since log files were not available for analysis.As a result, the reported event could not be confirmed.Applicable risk documentation and experience with events of similar circumstances were considered; a possible root cause of the reported ¿loose¿ driveline port can be attributed to, but not limited to, connector damage, bent pins and/or connector wiring failure.A possible root cause of the reported controller fault alarm can be attributed, but not limited to, the failure of the pump to restart and/or a controller malfunction.Based on risk documentation, multiple factors may have contributed to the high-power event including but not limited to thrombus formation/ingestion, high flows, or incorrect setting of alarm threshold.A possible root cause the reported pump vibration and grinding sound event may be attributed to multiple factors including but not limited to thrombus within the device leading to impeller imbalance or the placement of the pump which allows contact with fixed or rigid anatomical structure.Based on historical review of similar events, a possible cause of the failure of the pump to restart may be attributed, but not limited, to thrombus within the device and/or the inability of the pump-start algorithm to provide sufficient torque to overcome abnormally high mechanical resistance caused by unknown conditions that existed prior to the failed restart attempt.Investigation of this event is completed and the file will be closed.If new information is received, the file will be re-opened and a supplemental will be submitted.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 9818018
• MDR Text Key: 196418895
• Report Number: 3007042319-2020-01702
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/27/2020
• Initial Date FDA Received: 03/11/2020
• Supplement Dates Manufacturer Received: 04/23/2020
• Supplement Dates FDA Received: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention