MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0; VENTRICULAR (ASSISST) BYPASS

Model Number 1420

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/11/2023

Event Type  malfunction  

Event Description

It was reported that the controller had a loose power port.The controller was exchanged.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.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.

Manufacturer Narrative

A supplemental report is being submitted for device analysis.Product event summary: the controller (b)(6) was returned for evaluation.A review of the manufacturing documentation confirmed that the associated device met all requirements for release.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.Visual inspection of the controller revealed contamination within both power ports, the serial port, and the pump connectors.Visual inspection revealed scratches on the controller housing and a damaged serial port cap.Visual inspection under 10x magnification revealed hairline cracks on the housing near the serial port of the controller.Internal inspection revealed a crack on a standoff post within the controller housing.No evidence of fluid ingress was observed.These are additional findings not related to the reported event.The most likely root cause of the observed controller connectors contamination, scratches on the controller housing, and damaged serial port cap events can be attributed to the handling of the device.Based on an investigation conducted under capa (b)(4), the root cause of the hairline crack found at the corner of the controller was determined to be due to environmental stress cracking from a combination of chemical incompatibility and mechanical stresses.The chemical incompatibility is attributed to mineral oil leaching from the controller¿s housing gasket and migrating to the controller housing.The mechanical stresses are caused by the ultrasonic welding of inserts located within the corners¿ thinner wall.Based on an investigation, the root cause of the standoff post crack was determined to be due to mineral oil applied to the controller¿s internal main gasket and/or to the silicone adhesive applied around the controller¿s internal battery coming into contact with the standoff post.The mineral oil and/or silicone adhesive contributed to environmental stress cracking.Capa pr00517125 is investigating this issue.Analysis of the event log file revealed a controller power-up with an associated motor start event logged on (b)(6) 2023 at 18:42:44.The data point recorded prior to the loss of power revealed that the power adapter was connected to power port one (1) and (b)(6) was connected to power port two (2) with 78% rsoc.The data point recorded after the loss of power revealed that there was no connection to power port one (1) and (b)(6) was connected to power port two (2).The controller was without power for ten (10) seconds.No anomalies were observed leading up to the loss of power.Analysis of the alarm log file revealed one (1) vad disconnect alarm was logged on (b)(6) 2023 at 17:30:21 indicating a physical disconnection of the driveline from the controller likely due to the reported controller exchange.The observed loss of power event is an additional finding not related to the reported event.A possible root cause of the observed loss of power can be attributed to a disconnection of both power sources and/or to an intermittent disco nnection on one or both power sources.Capa (b)(4) is investigating controller losses of power.Failure analysis of the returned controller also revealed a loose, detached serial connector.Internal visual inspection also revealed a loose metal locknut from power port two (2) in the controller.A visual inspection under 10x magnification revealed that the thread of the connector did not have an adequate application of the loctite substance.As a result, the reported event was confirmed.As a result, the reported event was confirmed.The most likely root cause of the reported event can be attributed to improper assembly.Capa (b)(4) was opened to investigate loose connectors with controller 2.0.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 submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
• 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: 18237248
• MDR Text Key: 329368928
• Report Number: 3007042319-2023-04623
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2020
• Device Model Number: 1420
• Device Catalogue Number: 1420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: (B)(6).