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

Device Problem Loose or Intermittent Connection (1371)

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

Event Type  malfunction  

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.Other devices involved in this event: heartware ventricular assist system -controller.Controller / unk / model #: unk / expiration date: unk.Udi #: asku.Mfg date: unk.(b)(4).Heartware ventricular assist system ¿ controller dc adapter.Controller dc adapter / unk /model #: 1430 / expiration date: unk.Udi #: asku.Mfg date: unk.(b)(4).Concomitant medical products: product id: unk-controller.Product id: 1440.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient had loose power ports.The patient was advised to remove the controller dc adapter from service.The controller dc adapter was disposed and the primary and back-up controllers were exchanged.The patient was educated on new controllers.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: two controllers and one controller dc adapter with unknown serial numbers were not returned for evaluation.A review of the manufacturing documentation could not be performed because the serial numbers were unknown.Applicable risk documentation and experience with events of similar circumstances were considered; a possible root cause of loose power port connectors may be attributed to inadequate thread lock, an inconsistent thread lock cure time and an inadequate torque application during the assembly process.Additional products: controller unk.(b)(4).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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM- CONTROLLER
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 8275998
• MDR Text Key: 135370342
• Report Number: 3007042319-2019-00414
• 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
• Type of Report: Initial,Followup
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MCS UNKNOWN VAD
• Patient Age: 48 YR
• Patient Weight: 83