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

Model Number 1103

Device Problems Pumping Stopped (1503); Battery Problem (2885); Connection Problem (2900); Pumping Problem (3016); Material Split, Cut or Torn (4008)

Patient Problems Muscle Weakness (1967); Thrombosis/Thrombus (4440); Lactate Dehydrogenase Increased (4567)

Event Date 11/12/2021

Event Type  Injury  

Event Description

It was reported that the ventricular assist device (vad) patient was admitted for right sided weakness and elevated lactate dehydrogenase (ldh).Upon admission, a computerized tomography (ct) scan was performed and the result showed no stroke and the weakness resolved.It was suspected that the patient had thrombus in the vad and that the patient was therapeutic with their anticoagulation therapy.During admission a review of log files revealed that the vad exhibited high power, and that there was a double disconnect from the controller associated with a vad stop and that the battery did not provide power.Upon examining the controller it was noted that the also exhibited poor mechanical connection at the power ports as a pin was split.The patient was treated with anticoagulants and is being evaluated for transplant.The battery was removed from service and the controller was exchange and the vad remains in use.No further 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-controller/ catalog #: 1420-controller / expiration date: 28-feb-2022 / 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: 05-feb-2021.Labeled for single use: no.(b)(4).Brand name: heartware ventricular assist system ¿ battery , model #: 1650de / catalog #: 1650de / expiration date: 30-jun-2022 / 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: 23-jun-2021.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 device evaluation.Product event summary: the ventricular assist device (vad), the controller , and battery were not returned for evaluation.Log file analysis revealed a gradual increase in power consumption within the analyzed period.Additionally, a decrease in estimated flow associated with a change in the hematocrit setting was logged on 13-nov-2021.27 low flow alarms were logged since 10-oct-2021.Log file analysis also revealed two controller power-up events recorded on (b)(6) 2021 at 09:33:46 and on (b)(6) 2021 at 12:58:52.The data point prior to the first loss of power revealed that (b)(6) was connected to power port one with 97% relative state of charge (rsoc) and a power adapter was connected to power port two.The data point recorded after the first loss of power revealed that (b)(6) was connected to power port one and (b)(6) was connected to power port two.The data point prior to the second loss of power revealed that (b)(6) was connected to power port one with 99% rsoc and (b)(6) was connected to power port two with 51% rsoc.The data point recorded after the second loss of power revealed that (b)(6) was connected to power port one and no power source was connected to power port two.No anomalies were recorded leading up to the losses of power.The controller was without power for six seconds and eight seconds, respectively.As a result, the reported high power and controller loss of power events were confirmed.The reported controller poor mechanical connection/damaged power port pin event and the reported battery not providing power event could not be confirmed since the devices were not available for analysis.Information received from the site indicated that the patient presented with right sided weakness and elevated lactate dehydrogenase (ldh).A computerized tomography (ct) scan revealed no signs of stroke and the weakness resolved.It was suspected that the patient had a device thrombus and was treated with anticoagulants and evaluated for transplant.Based on the available information, the device may have caused or contributed to the reported event.Per the instructions for use, neurological dysfunction and thrombus are known potential complications associated with the implantation of a vad.There was no evidence that the patient had a history of similar adverse events.Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, the progression of their underlying disease, issues related to the therapeutic use of anticoagulant and antiplatelet medications and the patient's complex post-operative course.There are possible patient, pharmacological and procedural factors that may have contributed to this event.A possible root cause of the controller losses of power can be attributed to a disconnection of both power sources and/or to an inte rmittent disconnection on one or both power sources.Capa pr00551638 is investigating controller losses of power.Based on the risk documentation, possible root causes of the high power event may be attributed to multiple factors, including but not limited to external factors such as thrombus formation/ingestion and/or patient related factors.Based on the risk documentation, possible causes of the observed low flow event may be attributed to multiple factors including but not limited to thrombus at the inflow cannula/outflow graft, constriction at the outflow graft, poor vad filling, inappropriate pump rotational speed, and/or incorrect setting of the alarm threshold.Applicable risk documentation and experience with events of similar circumstances were considered; events involving a battery not providing power can be attributed, but not limited, to an internal battery communication error, a faulty integrated circuit, an improper weld, and/or a soldering defect.Based on historical review of similar events, a possible root cause of the reported controller poor mechanical connection/damaged pin event can be attributed to misalignment during connection attempts between the metal receptacles on the controller and the plastic connector plugs in the battery and/or adapter cables; the misalignment results in wear on the connector plugs that can lead to contact between the connector plug and socket pins from the controller, and the socket pins may not withstand applied forces from subsequent misaligned connections, causing the pins to bend.Additional products: d4: (b)(6) h6: fda method code(s): b15, b17 h6: fda results code(s): c19 h6: fda conclusion code(s): d14 d4: (b)(6) h6: fda method code(s): b15, b17 h6: fda results code(s): c19 h6: fda conclusion code(s): d15 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
• 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: 12883177
• MDR Text Key: 281340321
• Report Number: 3007042319-2021-08193
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707002639
• UDI-Public: 00888707002639
• 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: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2019
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2017
• 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: 6935M55, 5076-45 LEADS, DDMB1D4 ICD
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 41 YR
• Patient Sex: Male