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

Model Number 1103

Device Problems Increase in Suction (1604); Adverse Event Without Identified Device or Use Problem (2993); Pumping Problem (3016)

Patient Problems Dehydration (1807); Hemorrhage/Bleeding (1888)

Event Date 04/08/2021

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 was admitted for a suspected gastrointestinal bleed (gib) due to the fact the patient's hemoglobin (hgb) had dropped.An esophagogastroduodenoscopy (egd) was performed, which showed no findings.The patient received one unit of fresh frozen plasma (ffp) and two units of packed red blood cells (prbc).It was noted that the patient also had some epistaxis during admission, but there was no intervention done and it resolved on it's own.The patient's anticoagulation was seen to be subtherapeutic, and had been on aspirin and coumadin, but was seen to be non compliant with their anticoagulation medications.The ventricular assist device (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 device evaluation and additional information.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 revealed that the patient was suspected for gastrointestinal bleeding (gib).An esophagogastroduodenoscopy (egd) was performed and the patient received one unit of fresh frozen plasma (ffp) and two units of packed red blood cells (prbc).Of note, the patient had some epistaxis and was resolved by itself.The patient's anticoagulation was subtherapeutic and was on aspirin and coumadin, which has been non compliant with their medication.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 is a known potential complication 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 bleeding.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 information: b6 laboratory data: (b)(6) 2021: inr 1.8 (b)(6) 2021 : hgb 6.7 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

This regulatory report is being submitted as part of a retrospective review and remediation per d00595825 due to an fda audit observation.Report is being submitted for correction and additional information.Correction: b1.Adverse event or product: changed from adverse event to adverse event & product problem.B3.Date of event: changed from 2021-4-21 to 2021-04-08 b5.Event description updated.H6.Patient codes (ime/annex e): e1201 device codes (fdd/annex a): a1412, a141302 eval code method (fdm/annex b): b15 eval code result (frd/annex c): c19 imf (annex f) health impact: f2303 img (annex g) component: g04105 product event summary: the ventricular assist device (vad) was not returned for evaluation.The reported low flow/suction event was confirmed via review of the available autologs report, which revealed several instances of intermittent suction within the analyzed period and sixty eight (68) low flow alarms logged since 08/apr/2021.Information received from the site revealed that the patient was suspected for gastrointestinal bleeding (gib).An esophagogastroduodenoscopy (egd) was performed and the patient received one unit of fresh frozen plasma (ffp) and two units of packed red blood cells (prbc).Of note, the patient had some epistaxis and was resolved by itself.The patient's anticoagulation was subtherapeutic and was on aspirin and coumadin, which has been non compliant with their medication.It was further reported that the patient was admitted to the hospital from the clinic due to low flows and suction.It was noted that the patient was dehydrated.The vad speed was lowered and the patient was given ivf and encouraged to increase oral intake.Additionally, it was noted that there were low flow alarms.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/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 filling, and/or inappropriate pump rotational speed.Per the instructions for use, bleeding is a known potential complication 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 bleeding.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 patient was admitted to the hospital from the clinic due to low flows and suction.It was noted that the patient was dehydrated.The vad speed was lowered and the patient was given ivf and encouraged to increase oral intake.Additionally, it was noted that there were low flow alarms.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE
• 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: 11863434
• MDR Text Key: 251944824
• Report Number: 3007042319-2021-03691
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• 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
• Date Manufacturer Received: 03/30/2022
• Date Device Manufactured: 08/24/2020
• 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): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 78 KG