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

Model Number 1103

Device Problems Contamination (1120); Electrical /Electronic Property Problem (1198); Material Integrity Problem (2978); Pumping Problem (3016)

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

Event Date 12/26/2021

Event Type  Injury  

Event Description

It was reported that the ventricular assist device (vad) exhibited intermittent electrical fault alarms while the controller was connected to batteries.It was reported that a high watt alarm also occurred.It was observed that the driveline had tape all over.During review of log file data, it was also found that the controller had a loss of power.The patient remained asymptomatic.The patient was hospitalized and had a central line and arterial line placed for a splice repair.It was observed that the driveline wires were exposed and damaged and that the driveline connector was "very soiled".Each wire was crusted with greenish residue.The vad remains in service and a splice repair was completed.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.Additional products:brand name: heartware ventricular assist system ¿ controller 2.0, model #: 1420 / catalog #: 1420 / expiration date: 31-dec-2020 / serial #: (b)(4), udi #: (b)(4).Device available for evaluation: no.Device evaluated by mfr: no, device evaluation anticipated, but not yet begun.Mfg date: 06-dec-2019, labeled for single use : no.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

No further patient complications have been reported as a result of this event.

Manufacturer Narrative

A supplemental report is being submitted for device evaluation and a correction.B5 describe event or problem was corrected from "no patient complications have been reported as a result of this event." to "no further patient complications have been reported as a result of this event.".Product event summary: a segment of the driveline cable associated with (b)(6) and the controller ((b)(6)) were returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the devices in relation to the reported event.A review of the pump's manufacturing documentation confirmed that the associated device met all requirements for release.Failure analysis of the returned controller revealed that the device passed functional testing.Visual inspection of the returned controller revealed contamination within both power ports.This is an additional finding not related to the reported event, likely due to the handling of the device.Functional testing of the driveline segment revealed that the driveline passed the continuity and locking mechanism test.Visual inspection of the returned segment of driveline cable, as well as on-site visual examination and visual evidence provided by the site revealed that, proximal to the connector, there was damage to the outer sheath, inner lumen, and to the insulation of the red and white cable wires.Visual inspection also revealed breaks and yellowing of the outer sheath.On-site inspection of the driveline cable also revealed contamination at the site of the exposed wires and around the driveline connector.No contamination was observed within the returned driveline connector.Log file analysis associated with (b)(6) revealed several reactivation events, electrical fault alarms, a high watt alarm, and a vad disconnect alarm.Review of the event log file revealed several reactivation events since 23/dec/2021 indicating overcurrent conditions in the front and rear stator, resulting in the pump running on a single stator.Additionally, three (3) reactivation events were recorded on 09/mar/2022, indicating an open phase in the rear stator.Review of the alarm file revealed two (2) electrical fault alarms on 06/mar/2022 at 09:05:39 and 11:43:19 indicating an overcurrent condition in the rear stator, resulting in the pump running on a single stator.This likely triggered the subsequent hi gh watt alarm on 06/mar/2022 at 11:43:20, due to the increased power consumption required to run on a single stator.A third electrical fault alarm was recorded 06/mar/2022 at 13:00:33 indicating an overcurrent condition on the front stator.A fourth electrical fault alarm was recorded on 09/mar/2022 at 14:49:49 indicating an open phase in the rear stator.This was followed by a vad disconnect alarm on 09/mar/2022 at 14:57:06 indicating a physical disconnection of the driveline from the controller, likely during the splice repair procedure.In addition, log file analysis revealed one (1) controller power up event with an associated pump start event on 26/dec/2021 at 06:49:53.The data file covers data from 05/feb/2022 through 09/mar/2022, therefore the power sources connected before and after the controller loss of power event were not available for analysis.The controller was without power for fifteen (15) seconds.As a result, the reported events were confirmed.A driveline splice procedure was performed to mitigate the reported conditions.The most likely root cause of the reported contamination at the site of the exposed wires and around the outside of the driveline connector wires event can be attributed to handling of the device.Based on the available information, the damage to the driveline outer sheath was a progression of the previously reported damage.Based on historical review of similar events, the most likely root cause of the driveline sheath damage and observed yellowing may be attributed to multiple factors including design issues and/or exposure to uv light.Based on the available information, the most likely root cause of the reactivation events and electrical fault alarms due to overcurrent conditions and following high watt alarm can be attributed to shorts in the driveline due to damage to the driveline cable wires; when the wires were left exposed, the wires may have come in contact with each other, which would trigger electrical faults due to a short circuit.The most likely root cause of the observed damaged inner lumen and driveline cable wires can be attributed to handling of the device after the outer sheath damage left the inner lumen and driveline cables exposed.Based on the available information and investigation conducted, the most likely root cause of the reactivation events and electrical fault alarms due to open phases may be attributed, but not limited, to a marginal connection between the driveline and the controller.A possible root cause of the loss of power can be attributed to a disconnection of both power sources and/or to an intermittent disconnection on one or both power sources.Capa pr00551638 is investigating controller losses of power.Additional products: d4: serial #: (b)(6) d9: yes, return date: 29-mar-2022 h3: yes dev rtn to mfr? yes h6: img code(s): g04034 h6: fda method code(s): b01, b15 h6: fda results code(s): c04, c15 h6: fda conclusion code(s): d15, d11 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: 13725689
• MDR Text Key: 288992754
• Report Number: 3007042319-2022-02939
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: DDPB3D4 ICD, 5076-52 LEAD, 6935M62 LEAD
• Patient Outcome(s): Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 94 KG