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

Model Number 1103

Device Problems Obstruction of Flow (2423); Pumping Problem (3016)

Patient Problems Stroke/CVA (1770); Unspecified Infection (1930); Hernia (2240); Thrombosis/Thrombus (4440)

Event Date 02/16/2022

Event Type  Injury  

Event Description

It was reported that the ventricular assist device (vad) patient was admitted to the hospital with low flow alarms and shortness of breath.It was reported that the patient was on daily aspirin and international normalized ratio (inr) was 2.7 on admission.The patient was recently diagnosed with covid in (b)(6) 2022 and was reported to be on lifelong antibiotic and antifungal treatments for bacteremia and fungaemia (patient is status post multiple washout procedures due to left thoracotomy wound defect).It was reported that the patient was complaint with medications and treatments, except for blood glucose being uncontrolled.The patient had a suspected thrombus or outflow graft (ofg) obstruction.A transthoracic echocardiogram (tte) was done stat and showed no changes upon a quick assessment from prior study.A computed tomography angiography (cta) was done which showed an occlusion in the distal outflow of the ofg.The patient was stable on milrinone until taken to the operating room for ofg revision/debridement.Either pre-operation or intraoperatively, the patient had a large middle cerebral artery (mca) occlusion, with slight increase in vad powers right before going into the operating room, so timing of mca occlusion was questioned due to this finding.There was also below normal power consumption observed on log file data review.The patient was reported to have a brain herniation, care was subsequently withdrawn and the patient expired.An autopsy was declined by the family.

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.Additional product: brand name: heartware ventricular assist system ¿ outflow graft, model #: 1125 / catalog #: 1125 / expiration date:30-apr-2023 / lot#: 17299077-1069 udi #: (b)(4) / : implant date: (b)(6) 2019.Device available for evacuation?: no.Mfg date: 01-apr-2018.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 additional event information.Additional product: d4: lot#: 17299077-1069 h6: patient ime code(s): e0133 this information was received from the mechanical circulatory support product surveillance registry study.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 further reported that the relief of the outflow graft obstruction was successful.However, on the first post-operative day, the patient suffered a large mca territory stroke with midline and uncal herniation.Comfort measures were pursued prior to the patient¿s passing in the intensive care unit (icu).

Manufacturer Narrative

A supplemental report is being submitted for device evaluation and investigation completion.Product event summary: the pump and the associated outflow graft were not returned for evaluation.Review of the controller log files revealed a gradual decrease in power consumption and estimated flows beginning on (b)(6) 2022, leading to parameters below the normal operating range, and 42 low flow alarms logged since on (b)(6) 2022.This was followed by an increase in power consumption and estimated flows starting on (b)(6) 2022 leading to a return to baseline parameters.As a result, the reported low flow event was confirmed.Information provided by the site indicated that, in addition to low flows, the patient presented with shortness of breath.It was reported that the patient was recently diagnosed with covid and was on lifelong antibiotic and antifungal treatments for bacteremia and fungaemia.Thrombus was suspected and a computed tomography angiography (cta) showed an occlusion in the distal outflow of the outflow graft.The patient was taken to the operating room for outflow graft revision/debridement; the relief of the outflow graft obstruction was successful, which corresponds with the return to baseline parameters observed in the log files.However, on the first post-operative day, the patient suffered a large middle cerebral artery territory stroke with midline and uncal herniation.The patient was reported to have a brain herniation, care was subsequently withdrawn, and the patient expired.Based on the available information, the device may have caused or contributed to the reported event.Based on the risk documentation, possible causes of the reported 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, inappropriate pump rotational speed, and/or poor vad filling.Per the instructions for use, thrombus, neurological dysfunction, infection, and death are known potential complications associated with the implantation of a vad.Based on review of past adverse events for this patient, it was noted that the patient had a history of infection, thrombus, and ne urological dysfunction 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.Additional products: d4: serial no#: (b)(6); h3: yes; h6: fda method code(s): b17 h6: fda results code(s): c20 h6: fda conclusion code(s): d12.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.

Manufacturer Narrative

A supplemental report is being submitted for additional event details.B5 description or event problem was updated.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 further reported that multiple intravenous medications were administered including: fentanyl, glycopyrrolate, lorazepam, mannitol, human albumin, aztreonam, and calcium chloride.

Manufacturer Narrative

A supplemental report is being submitted for an update to investigation completion.Revised product event summary: the pump (b)(6) and the associated outflow graft (lot 17299077-1069) were not returned for evaluation.Review of the controller log files revealed a gradual decrease in power consumption and estimated flows beginning on 10/feb/2022, leading to parameters below the normal operating range, and 42 low flow alarms logged since (b)(6) 2022.This was followed by an increase in power consumption and estimated flows starting on (b)(6) 2022, leading to a return to baseline parameters.As a result, the reported low flow event was confirmed.Information provided by the site indicated that, in addition to low flows, the patient presented with shortness of breath.It was reported that the patient was recently diagnosed with covid and was on lifelong antibiotic and antifungal treatments for bacteremia and fungaemia.Thrombus was suspected and a computed tomography angiography (cta) showed an occlusion in the distal outflow of the outflow graft.The patient was taken to the operating room for outflow graft revision/debridement; the relief of the outflow graft obstruction was successful, which corresponds with the return to baseline parameters observed in the log files.However, on the first post-operative day, the patient suffered a large middle cerebral artery territory stroke with midline and uncal herniation.The patient was reported to have a brain herniation, care was subsequently withdrawn, and the patient expired.It was further reported that multiple intravenous medications had been administered.Based on the available information, the device may have caused or contributed to the reported event.Based on the risk documentation, possible causes of the reported 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, inappropriate pump rotational speed, and/or poor vad filling.Per the instructions for use, thrombus, neurological dysfunction, infection, and death are known potential complications associated with the implantation of a vad.Based on review of past adverse events for this patient, it was noted that the patient had a history of infection, thrombus, and neurological dysfunction 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.Additional products: d4: serial o#: (b)(6) 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: 13639136
• MDR Text Key: 286422507
• Report Number: 3007042319-2022-02753
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707003261
• UDI-Public: 00888707003261
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2020
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2018
• 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): Death
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 102 KG