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

Model Number 1104

Device Problems Electrical /Electronic Property Problem (1198); Pumping Stopped (1503); Material Integrity Problem (2978); Pumping Problem (3016); Material Split, Cut or Torn (4008)

Patient Problem Anxiety (2328)

Event Date 01/12/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient accidentally cut their driveline approximately 4 centimeters (cm) from the driveline exit site during a dressing change.Review of logfiles showed that the driveline wire damage caused a momentary short in front phase a and b.There was a front-stator over-current fault followed by a rear-stator over-current 2 seconds later, and a rear-stator-only start with at least two front phases open which appeared to result in a ventricular assist device (vad) stop.There were electrical fault alarms and high watt alarms and the vad was running on single stator operation.It was also reported that the patient was very scared and anxious.Two days later the patient was taken to the operating room (or) and a successful driveline splice repair was performed.The patient was equipped with a venous access, sedated and a catheter was placed close to the outflow graft.The vad remains 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 driveline cable was not returned for evaluation.Review of the manufacturing documentation confirmed that the associated device met all requirements for release.Log file analysis revealed one vad stopped alarm, two electrical fault alarms, and one high watts alarm were logged on 12-jan-2022.The vad stopped alarm was logged at 10:42:50, indicating that the motor stators failed.An electrical fault alarm was simultaneously recorded at the time of the vad stopped alarm due to an overcurrent condition on the rear stator, which resulted in the stators failing.The high watts alarm was logged at 10:43:03 due to the front stator not connected, indicative of the increased power consumption associated with the pump running on a single stator (rear stator).The second electrical fault alarm was logged at 13:01:59 due to the front stator not connected, causing the pump to run on a single stator (rear stator).On-site inspection of the driveline cable, as well as visual inspection provided by the site, revealed cut damage to the outer sheath and inner cable wires, near the driveline exit site and resulting in single stator operation.As a result, the re ported event was confirmed.Additionally, visual evidence also revealed discoloration of the outer sheath.Of note, it was reported that "the patient accidentally cut their driveline cable sheath with scissors.Information provided by the site indicated that two days later the patient was taken to the operating room (or) and then a driveline splice procedure was performed to mitigate the reported conditions.The observed driveline sheath discoloration event is an additional finding not related to the reported event.Based on the investigation conducted under capa00188, the most likely root cause of the driveline sheath discoloration may be attributed to multiple factors including design issues and/or exposure to uv light.Even though this capa is closed, hw1570 falls within the bounds of this capa.Based on the available information, the most likely root cause of the reported event can be attributed to the accidental cutting of the driveline by the patient, as mentioned in the reported event details; several wires may have come in contact with each other, which would trigger electrical faults due to a short circuit.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: 13308287
• MDR Text Key: 284130957
• Report Number: 3007042319-2022-00231
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1104
• Device Catalogue Number: 1104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2022
• 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
• Removal/Correction Number: Z-1751-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male