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

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

  • 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
 

THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA Back to Search Results
Catalog Number 106015
Device Problems Partial Blockage (1065); Infusion or Flow Problem (2964)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/22/2018
Event Type  Injury  
Manufacturer Narrative
The referenced outflow graft obstruction was reported under medwatch mfr report# 2916596-2017-02400. Age of device: 2 years, 3 months, 5 days. The patient remains on lvad support with no further issues reported. No further information was provided. A supplemental report will be submitted when the manufacturer's investigation is completed.
 
Event Description
The patient was implanted with left ventricular assist device (lvad) on (b)(6) 2016. It was reported that patient went to the hospital with low flows. A ct angiogram was performed which showed that the stent placed in the outflow graft migrated and a kinking was observed. A yellow tissue noticed between the goretex covering and outflow graft that could have contributed to the decreased flows. The outflow graft was replaced and flows returned to normal. No further information was provided.
 
Manufacturer Narrative
Investigation summary: the report of decrease in flow was confirmed through evaluation of the submitted log file, however, a specific cause for the decrease could not be determined as the product was not returned. Review of the submitted log file revealed that the pump operating at or above the low speed limit for the duration of the log file. Pump parameters were within acceptable limits. The log file appeared to show the system operating as intended. The patient was admitted and ct scan revealed a kinked outflow graft. The graft was replaced on (b)(6) 2018. Observed tissue between the goretex covering of the outflow graft may have contributed to decreased flows. The flow returned to acceptable levels. Multiple attempts for product return were issued to the customer with no product received to date. The surgical procedures section of the heartmateii lvas ifu outlines preparing and installing the sealed outflow graft, and instructs to verify that the graft is not twisted or kinked. Section 1 "introduction" of the heartmate ii lvas ifu provides an explanation of all pump parameters, including pump flow. The pump performance monitoring section explains that pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling and provides information regarding the assessment of pump flow. The patient remains ongoing on vad support with no further issues reported. No further information was provided. The manufacturer is closing the file on this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA
Type of DeviceLEFT VENTRICULAR ASSIST SYSTEM
Manufacturer (Section D)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 95488
MDR Report Key7624696
MDR Text Key111853817
Report Number2916596-2018-02497
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00813024011224
UDI-Public00813024011224
Combination Product (y/n)N
PMA/PMN Number
P060040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/31/2018
Device Catalogue Number106015
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/11/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/21/2018 Patient Sequence Number: 1
-
-