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

Model Number 1103

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

Patient Problems Hemorrhage/Bleeding (1888); Tachycardia (2095); Respiratory Failure (2484); Unspecified Kidney or Urinary Problem (4503); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/24/2020

Event Type  Death  

Manufacturer Narrative

This regulatory report is being submitted as part of a retrospective review and remediation per (b)(4) due to an fda audit observation.This information was received from the mechanical circulatory support product surveillance registry study.Product event summary: the ventricular assist device (vad) was not returned for evaluation.This complaint is associated with a clinical adverse event.Information received from the site indicated that the patient experienced mild bleeding, possibly from the gums; no intervention was required.It was further reported that the patient was in respiratory failure.It was stated that the patient was unresponsive and hypoxic and was started on positive pressure ventilation with ambu bag.A bougie was blindly placed, tracheal rings were felt.Endotracheal tube (ett) was secured, and patient was placed on ventilator.Patient also underwent a bronchoscopy and results showed thin secretions but no gastric or bloody content.Based on the available information, the device may have caused or contributed to the reported event.Per the instructions for use, bleeding and respiratory dysfunction 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 previously experienced a bleeding event.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.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 experienced mild bleeding possibly from gums.There was no required intervention.The vad remains in use.No further patient complications have been reported as a result of this event.It was further reported that the patient was in respiratory failure.It was stated that the patient was unresponsive and hypoxic and was started on positive pressure ventilation with ambu bag.A bougie was blindly placed, tracheal rings were felt.Endotracheal tube (ett) was secured, and patient was placed on ventilator.Patient also underwent a bronchoscopy and results showed thin secretions but no gastric or bloody content.

Event Description

It was further reported that the following day, the patient had an episode of respiratory failure which required emergency intubation and bronchoscopy.It was noticed by the anesthesiologist that there was blood in the oral cavity while intubating as well as copious secretions and ¿tfs¿; anticoagulant medication was held, and the patient¿s ventricular assist device (vad) speed was decreased to 2700 and pressor requirements were increased.In the morning, a significant amount of bleeding was noted from the patient¿s oral cavity and bilateral nares with about 150cc (cubic centimeter) of blood lost.Of note, there was no source of bleed.The patient continued to have persistent ventricular tachycardia (vt) after a suction event and remained on continuous renal replacement therapy (crrt).It was further reported that at this time a family meeting was called, and no further escalation continued.The patient experienced multiorgan dysfunction and subsequently expired.

Manufacturer Narrative

This regulatory report is being submitted as part of a retrospective review and remediation per d00700870.Corrected sections: - b1 adverse event or product: corrected from" adverse event" to "adverse event & product problem" - b2 outcome attributed to adverse event: corrected to check off ¿death¿ - b2 date of death: corrected to include date "(b)(6) 2020" - b5 desc evt problem: corrected to include additional adverse event experienced by the patient, diagnosis performed and product malfunction exhibited - b7 relevant history: corrected to include additional patient medical history - h1 type of reportable event: corrected from "serious injury" to "death" - h6 patient codes (ime/annex e), imf (annex f) health impact, device codes (fdd/annex a), img (annex g) component: corrected to include new annex codes that reflect the reported event.- h10 addt manufacturer for mdr: corrected the product event summary to include the reported event for adverse event and malfunction.Product event summary: ventricular assist device (vad) (b)(6) was not returned for evaluation.The reported suction event was not confirmed via review of the controller log files since log files were not available for analysis.Information received from the site indicated that the patient experienced mild bleeding, possibly from the gums; no intervention was required.It was further reported that the patient was in respiratory failure.It was stated that the patient was unresponsive and hypoxic and was started on positive pressure ventilation with ambu bag.A bougie was blindly placed, tracheal rings were felt.Endotracheal tube (ett) was secured, and patient was placed on ventilator.Patient also underwent a bronchoscopy and results showed thin secretions but no gastric or bloody content.It was further reported that the following day, the patient had an episode of respiratory failure which required emergency intubation and bronchoscopy.It was noticed by the anesthesiologist that there was blood in the oral cavity while intubating as well as copious secretions and ¿tfs¿; anticoagulant medication was held, and the patient¿s vad speed was decreased, and pressor requirements were increased.In the morning, a significant amount of bleeding was noted from the patient¿s oral cavity and bilateral nares.Of note, there was no source of bleed.The patient continued to have persistent ventricular tachycardia (vt) after a suction event and remained on continuous renal replacement therapy (crrt).At this time a family meeting was called, and no further escalation continued.The patient experienced multiorgan dysfunction and subsequently expired.Based on the available information, the device may have caused or contributed to the reported event.Based on the risk documentation, multiple factors may have contributed to the reported suction event including but not limited to thrombus at the inflow cannula/outflow graft, constriction at the outflow graft, poor vad filling, inappropriate pump rotational speed.Per the instructions for use, bleeding, respiratory dysfunction, renal dysfunction, cardiac arrhythmia, multi-organ failure 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 previously experienced bleeding, respiratory dysfunction, cardiac arrhythmia, and renal 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 is 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: 14338621
• MDR Text Key: 291231388
• Report Number: 3007042319-2022-05017
• 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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2020
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2022
• Date Device Manufactured: 08/17/2018
• 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; Required Intervention
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Race: White