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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS; LEFT VENTRICULAR ASSIST DEVICE

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THORATEC CORPORATION HEARTMATE II LVAS; LEFT VENTRICULAR ASSIST DEVICE Back to Search Results
Catalog Number 106524
Device Problems Migration or Expulsion of Device (1395); Infusion or Flow Problem (2964)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/24/2018
Event Type  Injury  
Manufacturer Narrative
The heartmate 3 lvas was implanted during the (b)(6) clinical trial, ide (b)(4).Fda approval for heartmate 3 lvas was received on 23 august 2017.The same device is used commercially and in the ongoing (b)(6) trial.(b)(4).Approximate age of device - 110 days.The patient remains on lvad support.No additional information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.
 
Event Description
The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2017.It was reported that frequent low flow alarms occurred the morning of (b)(6) 2018.The patient was medically managed; however, the low flow alarms persisted.As part of troubleshooting, the system controller was exchanged; however, the change did not resolve the alarms.The lvad speed was manually decreased; however, the alarms persisted.On (b)(6) 2018, the patient continued to be asymptomatic.The patient's left ventricle had decreased in size by 3 cm.Because of this remodeling, the inflow cannula had likely changed position enough to cause the low flow alarms.No additional interventions were pursued, and the patient was discharged.
 
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Brand Name
HEARTMATE II LVAS
Type of Device
LEFT VENTRICULAR ASSIST DEVICE
Manufacturer (Section D)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 94588
Manufacturer (Section G)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 94588
Manufacturer Contact
bob fryc
6101 stoneridge dr.
pleasanton, CA 94588
7818528390
MDR Report Key7300387
MDR Text Key101083741
Report Number2916596-2018-00710
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Health Professional
Type of Report Initial
Report Date 02/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/31/2020
Device Catalogue Number106524
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/30/2018
Initial Date FDA Received02/27/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/14/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age66 YR
Patient Weight99
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