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

Model Number 1104

Device Problems Disconnection (1171); Appropriate Term/Code Not Available (3191); Device Fell (4014)

Patient Problem Unspecified Nervous System Problem (4426)

Event Date 03/23/2022

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient accidently dropped the controller, and the ventricular assist device (vad) driveline became disconnected.The next day, the patient was admitted for a stroke.It was noticed that the vad driveline cover was missing for an unknown reason.The vad, driveline and controller remain in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

A supplemental report is being submitted for device evaluation.Product event summary: the ventricular assist device (vad), one (1) controller, and the driveline boot cover were not returned for evaluation.Review of the controller log files revealed five (5) vad disconnect alarms logged between 22-mar-2022 and 24-mar-2022 indicative of physical disconnections of the driveline from the controller.One (1) additional vad disconnect alarm was logged on 31-mar-2022 at 17:50:13 due to a critical phase open, indicating there was an open phase on each stator.As a result, the reported driveline disconnection event was confirmed.The reported missing driveline boot cover event could not be confirmed due to insufficient evidence.The initial vad disconnect alarms may be attributed but not limited to the handling of the device, including the reported controller drop event described in the event details.A possible root cause of the final vad disconnect alarm due to a critical phase open can be attributed, but not limited, to contamination by foreign material of the driveline connector and/or a marginal driveline connection.Based on the limited information available, a possible root cause of the reported missing driveline boot cover event can be attributed to an error during initial setup of the system at the time of implant and/or the handing of the device.Informat ion received from the site indicated that, the day after the reported controller drop event, the patient was admitted due to a stroke.Based on the available information, the device may have caused or contributed to the reported event.Per the instructions for use, stroke is a known potential complication associated with the implantation of a vad.There was no evidence that the patient had a h istory of neurological dysfunction events.Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, the progression of their underlying disease, issues related to the therapeutic use of anticoagulant and antiplatelet medications and the patient's complex post-operative course.There are possible patient, pharmacological and procedural factors that may have contributed to this event.Additional products: d4: serial or lot#: (b)(6), h3: yes h6: img code(s): g04034 h6: fda method code(s): b17, b15 h6: fda results code(s): c04, c23 h6: fda conclusion code(s): d15, d11 d4: serial or lot#: unknown - driveline cover h6: fda method code(s): b17 h6: fda results code(s): c20 h6: fda conclusion code(s): d14 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.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 - PUMP/DRIVELINE
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 14077297
• MDR Text Key: 293630091
• Report Number: 3007042319-2022-04645
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2020
• Device Model Number: 1104
• Device Catalogue Number: 1104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2018
• 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): Required Intervention; Hospitalization