• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE VENTRICULAR (ASSISST) BYPASS Back to Search Results
Device Problem Malposition of Device (2616)
Patient Problem Tachycardia (2095)
Event Date 01/04/2019
Event Type  Injury  
Manufacturer Narrative
This information is based entirely on journal literature. Medtronic was made aware of this event through a search of literature publications. The event only occurred with one patient but specific details on the patient were not provided. The model listed in the report is a representative of the model family, as there is no specific model listed. Without a lot number or device serial number, the manufacturing date cannot be determined. Since no device id was provided, it is unknown if this event has been previously reported. A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly. Referenced article: mobile inflow cannula leading to positional ventricular tachycardia. Artificial organs. 2019;43:699¿700. Doi: 10. 1111/aor. 13405 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
A journal article was reviewed that contained information regarding mobile inflow cannula leading to positional ventricular tachycardia. The article reports a patient implanted with a left ventricular assist device (vad) who soon after the surgery, experienced recurrent symptomatic positional monomorphic ventricular tachycardia (vt) with movement compromising ambulation and recovery. Multiple antiarrhythmic drugs and ablations failed to eradicate the vt. Transthoracic echocardiograms were performed with the patient resting in the supine position and with movement. These revealed the initiation and termination of symptomatic vt, which suggested mechanical stimulation of the myocardium as the source for vt. Repeat thoracotomy was performed, and the pump housing was repositioned. Thereafter, vt resolved, and the vad appears to be still in use. No further patient complications have been reported as a result of this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE
Type of DeviceVENTRICULAR (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 Key15015664
MDR Text Key295891964
Report Number3007042319-2022-06550
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/30/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/14/2022 Patient Sequence Number: 1
-
-