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

Model Number 1103

Device Problem Pumping Problem (3016)

Patient Problems Abdominal Pain (1685); Fall (1848); Fever (1858); Hemorrhage/Bleeding (1888); Liver Damage/Dysfunction (1954); Sepsis (2067); Ascites (2596); Syncope/Fainting (4411); Fecal Incontinence (4571)

Event Date 06/20/2022

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.This information was received from the mechanical circulatory support product surveillance registry study.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the ventricular assist device (vad) patient was admitted for a syncopal episode.A blood culture was taken and was positive for gastrointestinal sepsis.A computerized tomography (ct) scan was performed and revealed slightly nodular contour of the liver which raised concern for cirrhosis.A splenomegaly containing a few infarcts, and a small amount of ascites likely containing hemorrhagic products were also found.It was noted that the site of bleeding was the spleen.It was also noted that the patient had a fecal incontinence episode, low flow alarm, a fever, and white blood cell count (wbc) of 13.Three days later the patient had a hemoglobin or 6.9, a hematocrit of 20%, a wbc of 233.6, a red blood cell (rbc) count of 2.42, a platelet count of 164, and a partial thromboplastin time (aptt) of 36.5.Packed red blood cells (prbc) were given.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 investigation completion.Product event summary: the ventricular assist device (vad) was not returned for evaluation.The reported low flow event could not be confirmed since log files were not available for analysis.Information received from the site indicated that the patient was admitted for a syncopal episode.A blood culture was positive for lactobacillus associated with gastrointestinal sepsis, and a computerized tomography (ct) scan revealed slightly nodular contour of the liver which raised concern for cirrhosis.A splenomegaly containing a few infarcts and a small amount of ascites likely containing hemorrhagic products were also found.It was noted that there was bleeding from the spleen.Additionally, the patient had a fecal incontinence episode, a fever, and white blood cell count of 13.A blood transfusion was given.It was also stated that the patient fell down, which may have caused the hematoma.The patient also complained of abdominal pain, and there was abdominal tenderness in the left upper quadrant and left lower quadrant, and a ct scan showed the spleen displaced medially due to the large hematoma.An exploratory laparotomy, splenectomy, and clot evacuation were performed, and the patient was treated with intravenous cefepime and vancomycin.It was further reported that the vad was explanted due to infection.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, poor vad filling, and/or inappropriate pump rotational speed.Per the instructions for use, bleeding, hepatic dysfunction, infection, and syncope 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 and bleeding 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.

Manufacturer Narrative

A supplemental report is being submitted for additional event details.The event description and the annex e codes have been 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 the cultures were positive for lactobacillus and that the sepsis might have came from the driveline.It was also stated that the patient fell down and apparently this could had cause the large hematoma, taking into account that the patient was on anticoagulation therapy.The patient complained of abdominal pain , there was abdominal tenderness in the left upper qua drant and left lower quadrant and a ct scan showed the spleen displaced medially due to large hematoma.An exploratory laparotomy , splenectomy and clot evacuation was performed.

Manufacturer Narrative

A supplemental report is being submitted for additional information.Additional information was received indicating that the patient was treated with intravenous (iv) cefepime and iv vancomycin; b5 updated accordingly.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 patient was treated with intravenous (iv) cefepime and iv vancomycin.

Event Description

It was further reported that the vad was explanted due to infection and was not replaced.

Manufacturer Narrative

A supplemental report is being submitted for an update to: -b5.Desc evt problem -imf (annex f) health impact 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.

• 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: 14886807
• MDR Text Key: 295130991
• Report Number: 3007042319-2022-06362
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2022
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2022
• Initial Date FDA Received: 07/01/2022
• Supplement Dates Manufacturer Received: 07/15/2022; 08/01/2022; 08/03/2022; 08/25/2022
• Supplement Dates FDA Received: 07/25/2022; 08/04/2022; 08/11/2022; 09/01/2022
• Date Device Manufactured: 08/25/2020
• 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): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White