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U.S. Department of Health and Human Services

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

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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP; VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 1104
Device Problem Fitting Problem (2183)
Patient Problem Blood Loss (2597)
Event Date 05/20/2020
Event Type  Injury  
Manufacturer Narrative
This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation and destination therapy in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings.Additional product: heartware ventricular assist system ¿ accessories hvad implant kit, model #: 1153- / catalog #: 1153- / expiration date: 31-apr-2021 / serial or lot #: (b)(4), udi #: (b)(4).Device available for evaluation: no.Mfg date: 01-apr-2019.Labeled for single use: yes.(b)(4).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 during the off pump thoracotomy of ventricular assist device (vad) implant procedure, the surgeon had a difficulty inserting the pump through the sewing ring.The surgeon thought the o-ring was damaged as the patient was bleeding around the inflow cannula due to inadequate seal between the sewing ring and o-ring.The surgeon loosened the sewing ring and made some adjustments to the o-ring, made sure the pump inflow was flush with the sewing ring, secured the pump in place and tightened the screw on the sewing ring.Hemostasis was then established and there was minimal to no bleeding.The vad was implanted and remains in use with the sewing ring.No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
A supplemental report is being submitted for device evaluation product event summary: the ventricular assist device (vad) as well as the sewing ring associated with implant kit, were not returned for evaluation.The re ported event could not be confirmed due to insufficient evidence.There is no evidence to suggest that a device malfunction caused or contributed to the reported event.As per the hvad instructions for use (ifu), during the implant procedure, the sewing ring housing must be ensured to be flush with the hvad pump housing.Based on historical review of similar events, multiple factors may have contributed to the reported event including, but not limited to, operator's technique and/or incorrect setup.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.
 
Event Description
It was reported that during the off pump thoracotomy of ventricular assist device (vad) implant procedure, the surgeon had a difficulty inserting the pump through the sewing ring.The surgeon thought the o-ring was damaged as the patient was bleeding around the inflow cannula due to inadequate seal between the sewing ring and o-ring.The surgeon loosened the sewing ring and made some adjustments to the o-ring, made sure the pump inflow was flush with the sewing ring, secured the pump in place and tightened the screw on the sewing ring.Hemostasis was then established and there was minimal to no bleeding.The vad was implanted and remains in use with the sewing ring.No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
A supplemental report is being submitted for a correction.Corrected fields: h1 type of report: updated to serious injury outcome attributed to adverse event selected in b2 this regulatory report is being submitted as part of a retrospective review and remediation per (b)(4) due to an fda audit observation.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.
 
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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 Key10080568
MDR Text Key242615273
Report Number3007042319-2020-03280
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P100047
Number of Events Reported1
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
Report Date 12/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date04/30/2021
Device Model Number1104
Device Catalogue Number1104
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/06/2021
Date Device Manufactured04/01/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age58 YR
Patient SexMale
Patient Weight66 KG
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