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

Model Number 1104

Device Problems Increase in Suction (1604); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Hematoma (1884); Hemorrhage/Bleeding (1888); Hypoxia (1918); Unspecified Infection (1930); Muscle Weakness (1967); Renal Failure (2041)

Event Date 10/31/2020

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient presented with coughing and shortness of breath and blood was noted in sputum.The patient was intubated with for hypoxia for 24 hours and had international normalized ratio (inr) greater than 3.The patient was noted to have been on post-op antibiotics for bariatric surgery weeks before.A computerized tomography (ct) was done with multiple contrast ct scans,revealing a bleed at the rectus muscle and pseudo aneurysm around arterial line.Interventional radiology was done to stop the bleed.Mean arterial pressure (map) was 40 during the scans and renal failure developed as a result of the mean arterial pressure (map) and contrast dye.Patient requires dialysis for renal failure and was placed on intravenous (iv) heparin.The patient is now stable.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 additional information.Newly received information indicated that the patient had multiple hematomas needing two embolizations in interventional radiology; b5 updated.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 patient had multiple hematomas needing two embolizations in interventional radiology.

Event Description

It was further reported that the patient was too weak and sick for a ventricular assist device (vad) exchange.It was noted that the plan was to treat the patient with antibiotics until they are a candidate for transplant.

Manufacturer Narrative

Corrections: d4, h4 a supplemental report is being submitted for additional information and corrections.D4 expiration date corrected to 31-jul-2019.H4 device manufacture date corrected to 31-jul-2017.Newly received information indicated that the patient was too weak and sick for a ventricular assist device (vad) exchange.It was noted that the plan was to treat the patient with antibiotics until they are a candidate for transplant.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: the ventricular assist device (vad) was not returned for evaluation.This complaint is associated with a clinical adverse event.Information provided by the site revealed that the patient presented with coughing, shortness of breath, and blood was noted in sputum.The patient was intubated with for hypoxia for 24 hours and was noted to be on post-op antibiotics for bariatric surgery previously performed.A computerized tomography (ct) was done which revealed a bleed at the rectus muscle and pseudo aneurysm around arterial line.Additionally, multiple hematomas requiring two embolizations were identified.Interventional radiology was done to stop the bleed.Furthermore, the patient was placed in dialysis for renal failure and received intravenous heparin.The patient was also planned to start with antibiotic treatment until transplant.Based on the available information, there is no evidence to indicate that a device malfunction or performance issue caused or contributed to the reported event.Per the instructions for use, bleeding and renal dysfunction 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.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.

Event Description

It was further reported that the source of the infection was the ventricular assist device (vad) pocket which was confirmed with positive blood cultures.It was also reported that the vad had constant suctions which resulted in lowering the vad speed.

Manufacturer Narrative

A supplemental this regulatory report is being submitted as part of a retrospective review and remediation per d00595825 due to an fda audit observation.A correction supplemental report is being submitted for additional adverse event and malfunction details.Product event summary: the ventricular assist device (vad) (b)(6) was not returned for evaluation.The reported suction event could not be confirmed via review of the controller log files since log files were not available for analysis.Information provided by the site revealed that the patient presented with coughing, shortness of breath, and blood was noted in sputum.The patient was intubated with for hypoxia for 24 hours and was noted to be on post-op antibiotics for bariatric surgery previously performed.A computerized tomography (ct) was done which revealed a bleed at the rectus muscle and pseudo aneurysm around arterial line.Additionally, multiple hematomas requiring two embolizations were identified.Interventional radiology was done to stop the bleed.Furthermore, the patient was placed in dialysis for renal failure and received intravenous heparin.The patient was also planned to start with antibiotic treatment until transplant.It was further reported that the source of the infection was the ventricular assist device (vad) pocket which was confirmed with positive blood cultures.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 suction 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 fil ling, inappropriate pump rotational speed.Per the instructions for use, bleeding, renal dysfunction, respiratory dysfunction, and infection 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 anticoag ulant 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.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: 10884789
• MDR Text Key: 217666498
• Report Number: 3007042319-2020-07416
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2019
• Device Model Number: 1104
• Device Catalogue Number: 1104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2021
• Date Device Manufactured: 07/31/2017
• 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
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Female