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

Model Number 1103

Device Problems Contamination (1120); Electrical /Electronic Property Problem (1198); Material Integrity Problem (2978); Power Problem (3010)

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

Event Date 02/01/2023

Event Type  Injury  

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.

Event Description

It was reported that the ventricular assist device driveline sheath was damaged and electrical fault alarms occurred.Log files show a history of electrical faults on both motors at different times which was suspected to be caused by the driveline damage.Servicing will be performed. the vad driveline remains in use.No patient complications have been reported as a result of this event.

Event Description

It was further reported that the patient was admitted and a driveline splice repair was performed.Inspection of the driveline during servicing showed missing insulation in the wires close to the strain relief.It was noted that insulation was missing on both the rear and front stator wires.Dirt was also noted on the driveline connector.It was stated that a review of log files showed shorts starting four months prior, and the shorts were noticed on both the rear and front stator.The controller also exhibited multiple unexpected losses of power which were attributed to damage to the driveline wires.The controller remains in use.

Manufacturer Narrative

A supplemental rr is being submitted for corrections to b1, b2, b3, b5, h6 and h10.Additional products: d1: heartware ventricular assist system ¿ controller d4: model#: 1420 / catalog#: 1420 / expiration date: 30-apr-2023 / serial#: (b)(6) udi#: (b)(4) d9: no h3: no, device evaluation anticipated, but not yet begun h4: mfg date: 08-apr-2022 h5: no h6: the codes present in section h6 correspond to components/products that comprise the reported event.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.Product event summary: a segment of the driveline cable associated with the ventricular assist device (vad) (b)(6) was returned for evaluation.The controller (b)(6) was not returned was not returned for evaluation.Review of (b)(6) manufacturing documentation confirmed that the associated device met all requirements for release.There was no evidence that (b)(6) had previously been serviced by a medtronic employee.Various analyses were conducted and reviewed in order to evaluate the performance of the returned device in relation to the reported event.Failure analysis of the returned segment of the driveline cable revealed that the device passed functional testing.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 there were several cracks on outer sheath, as well as damage to the inner lumen and conductor wires insultation beneath a crack near the driveline strain relief; the wires with the damaged cable insultation were associated with the front and rear stators.Visual inspection, and onsite inspection, also revealed damage to the driveline strain relief, yellowing of the outer sheath, and contamination within and on the driveline connector.Functional testing of the driveline segment revealed that the driveline passed the continuity and locking mechanism test.Of note, despite the observed contamination, no alarms or reactivation events were triggered during functional testing of the driveline cable segment.Review of the event log file revealed 7 controller power up with associated pump start events were logged between 09/apr/2023 and 28 /jul/2023, indicating losses of power to the controller.The controller was without power for an average of 11 seconds.Data log files covering the losses of power events between 09/apr/2023 and 08/may/2023 were not available for analysis.No anomalies were observed leading up to the remaining losses of power.Log files also revealed 8 electrical fault alarms, 7 high watt alarms, and 32 reactivation events were logged between 25/feb/2023 and 07/aug/2023.4 electrical fault alarms were logged between 25/feb/2023 and 28/jul/2023 due to an overcurrent condition in the rear stator resulting in the pump running on a single stator (front stator only).4 electrical fault alarms were logged between 28/may/2023 and 28/jul/2023 due to an overcurrent condition in the front stator resulting in the pump running on a single stator (rear stator only).The high watt alarms were logged since 28/may/2023 due to the increased power consumption required to run on a single stator.The reactivation events were logged between 25/feb/2023 and 07/aug/2023 due to an overcurrent condition in the front stators and the rear stators, resulting in the pump running in single stator operation.As a result, the reported events were confirmed.Of note, (b)(6) was loaded with a software containing an unapproved pump start algorithm.A driveline splice procedure was performed to mitigate the reported conditions.Based on historical review of similar events, the most likely root cause of the reported driveline sheath damage and observed discoloration may be attributed to multiple factors including design issues and/or exposure to uv light.A possible root cause of the observed inner lumen damage may be attributed to handling of the device and/or wear over time without the outer sheath present.A possible root cause of the damage to driveline cable wires may be attributed to the handling of the device after the outer sheath damage left the driveline cables exposed.A possible root cause of the observed driveline strain relief damage may be attributed, but not limited, to wear and/or the handling of the device.The most likely root cause of the reported contamination event can be attributed to handling of the device; however, the contamination did not affect functional testing of the returned driveline segment.The most likely root cause of the electrical fault alarms, high watt alarms, reactivations, and overcurrent condition events can be attributed to the damage to the driveline cable wires; sev eral wires may have come in contact with each other, which would trigger electrical faults due to a short circuit.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: brand name: controller d4: (b)(6) h3: yes h6: the codes present in section h6 correspond to components/products that comprise the reported event.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 - 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: 17498548
• MDR Text Key: 321137472
• Report Number: 3007042319-2023-03301
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• 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: 12/08/2023
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 78 KG