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

Model Number 1103

Device Problems Electrical /Electronic Property Problem (1198); Difficult to Remove (1528); Material Integrity Problem (2978)

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

Event Date 10/30/2021

Event Type  malfunction  

Event Description

It was reported that the controller exhibited a controller fault alarm.The patient presented to the ventricular assist device (vad) engineer for controller exchange and it was noted that the driveline boot cover was stiff and unable to be pulled back by hand.A heat gun was used to soften the boot cover enough for it to be pulled back and the controller exchanged was performed.The boot cover was left on the driveline and pushed back over the connector, where it is again unable to be pulled back manually.It was noted that the driveline sheath had a small gap in the previous sheath repair.The driveline boot cover was then removed and a driveline sheath repair service was performed.The controller and boot cover were exchanged and the driveline remains in use.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.Additional products: brand name: heartware ventricular assist system ¿ controller 2.0 model #: 1402-controller , catalog #: 1402-controller , expiration date: 31-jul-2018 , serial #: (b)(4), udi #: (b)(4), device available for evaluation: no, no, device evaluation anticipated, but not yet begun , mfg date: 31-jul-2017, labeled for single use: no, (b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

A supplemental report is being submitted for corrections to: additional products: from: brand name: heartware ventricular assist system ¿ driveline cover d4: lot#: unk to: additional products: brand name: heartware ventricular assist system ¿ driveline cover d4: lot#: r016397.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 evaluation and investigation completion.Product event summary: the driveline cover (lot no.R016397) was returned for evaluation.The driveline cable associated with hw23781 and con309345 were not returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.Review of the pump's manufacturing documentation and the driveline cover's inspection records confirmed that the associated devices met all requirements for release.On-site inspection, as well as visual evidence provided by the site revealed that a previous repair of the driveline cable was worn out, thus confirming the reported event.Additionally, visual evidence provided by the site revealed damage in the driveline strain relief.A driveline sheath repair, which involved taping over the previous repair, was performed to mitigate the conditions reported.On-site inspection also revealed that the driveline cover was stuck on the driveline and could not be removed.Visual inspection of the returned driveline cover revealed that the driveline cover was received in a damaged condition; therefore, functional testing and dimensional verification could not be performed.Additionally, visual inspection revealed foreign material within the driveline cover.Supplemental testing previously performed on similar samples revealed that the driveline covers analyzed exhibited increased hardness and material stiffness as compared to a control sample.Review of the controller log files revealed two controller power up events on 30-oct-2021 at 17:26:42 and 18:46:16; prior to the power up events, the controller last had power on 09-aug-2021, indicating that the controller was put into use following the reported controller exchange and was likely the backup controller at the time of the reported event.Of note, the available data log file did not cover the reported event date.The alarm log file did not reveal any controller fault alarms during the analyzed period.Additionally, log files from the primary controller in use prior to the controller exchange were not available for analysis.Based on the reported event details, the controller fault alarm likely occurred on the primary controller.As a result, the reported controller fault alarm event could not be confirmed.The reported stuck boot cover and driveline repair damage events were confirmed.Applicable risk documentation, experience with events of similar circumstances, and the available information were considered; a possible root cause of the reported controller fault alarm may be attributed, but not limited, to a reduced charge capacity of the internal battery and/or a faulty internal battery charger integrated circuit.Based on historical review of similar events and the investigation conducted, a possible root cause of the reported difficulty removing the driveline cover event can be attributed, but not limited, to leaching of the plasticizer from the material and/or degradation of the material, resulting in hardening.Capa pr00536773 is further investigating this issue.Based on the available information, the most likely root cause of the driveline strain relief and repair damages may be attributed to factors such as normal wear over time and/or improper handling.Additional products: d4: serial #: con309345 h3: yes h6: fda method code(s): b15, b17 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 d4: lot#: r016397 d10: yes, return date: 20-jan-2022 h3: yes dev rtn to mfr? yes h6: fda method code(s): b01, b14, b15 h6: fda results code(s): c06, c07 h6: fda conclusion code(s): d1501 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.

Manufacturer Narrative

A supplemental report is being submitted for inclusion of this event as being in-scope for field action 3007042319-12-06-2022-005-c.This event was submitted historically and has been deemed in-scope for the field corrective action.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 - 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: 13097625
• MDR Text Key: 290564050
• Report Number: 3007042319-2021-08454
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707000017
• UDI-Public: 00888707000017
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2017
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 300704231912062022005C
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male