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


  • 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

Catalog Number 106524
Device Problem Partial Blockage (1065)
Patient Problems Hemolysis (1886); Right Ventricular Failure (2055)
Event Date 04/05/2018
Event Type  Injury  
Manufacturer Narrative
The initial submission of this event was reported by the manufacturer under mfr report # 2916596-2018-01596. This report is being submitted as additional information. The heartmate 3 lvas was implanted during the momentum 3 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 momentum 3 trial. The gtin unique device identifier for the commercial heartmate3 lvas is (b)(4). Approximate age of device ¿ 7 months. Manufacturer's investigation conclusion: "he" evaluation of heartmate 3 left ventricular assist system (lvas) confirmed the report of outflow graft twisting, which could have contributed to the observed low flow alarms in the submitted log files. The device was returned assembled with the pump cable severed approximately 6¿ from the bend relief and a 4¿ portion of the severed cable was returned. The modular cable was not returned. The sealed outflow graft attachment was returned attached to the pump cover outlet port. The apical cuff was returned, properly engage with the cuff lock. The graft beneath the bend relief revealed a 180-degree counter clockwise twist of the proximal end of the outflow graft less than 1¿ from the outflow graft hardware. The tissue accumulation on the exterior of the graft appeared to have formed around the twist, suggesting that the graft had been twisted for an undetermined period of time while the device was supporting the patient. Although a duration of time for which a twist was present could not be determined through this evaluation, it could have contributed to the low flow alarms that were confirmed through the submitted log files. Upon disassembly of the returned pump, depositions of clotted post explant blood were observed in one of the vanes of the rotor and in the pump cover. The remaining pump blood contacting surfaces were free from any adhered depositions or thrombus formations. The device was cleaned, rebuilt, and tested under load conditions on a mock circulatory loop. The pump functioned as intended. Corrective action has been taken to further investigate sealed outflow graft kinks/twists. The surgical procedures section contains information on "preparing the sealed outflow graft. " the "attaching the sealed outflow graft to the pump" section instructs the user to verify that the graft is not twisted or kinked by checking the position of the black line on the graft above and below the bend relief and ensuring that the line is straight. The "de-airing the pump" section explains that when de-airing is completed, slide the bend relief over the metal fitting of the sealed outflow graft toward the locking screw ring. This section warns that failure to connect the bend relief so that it is fully and evenly connected can allow kinking and abrasion of the graft, which may to serious adverse events such as low left ventricular assist device flow and/or bleeding. The system monitor section describes the pump flow display and the hazard alarms. The ifu states that the low flow hazard alarm will be triggered when pump flow is less than 2. 5 lpm and explains that changes in patient conditions can result in low flow. The alarms and troubleshooting section describes the actions to take in the event of a low flow alarm. A review of the device history records revealed the device met applicable specifications. No further information was provided. The manufacturer is closing the file on this event.
Event Description
The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2017. It was reported that the lvad system produced low flow alarms. The patient experienced shortness of breath secondary to anxiety, and was admitted. The following morning the patient was stable. Echocardiogram (echo) did not reveal any device issues, but did reveal right heart dysfunction, and the lvad speed was increased. There was no distinguishable change in left ventricular size with speed changes. Dobutamine and nipride were started. Ct scan with direct contrast revealed little flow coming from the pump. There was concern for outflow graft obstruction, and the patient¿s lactate dehydrogenase (ldh) was 400 u/l. On (b)(6) 2018 ct scan with contrast revealed an obstructed outflow graft. On (b)(6) 2018 it was reported that the patient was still admitted and stable on inotropes. The patient had multiple angiograms to evaluate flow through the pump, all of which were consistent with limited to no flow. The patient was being supported with inotropes and had a pa catheter for hemodynamic monitoring. There were no plans for outflow graft revision unless the patient became unstable. The patient was evaluated for transplant. No additional information was provided. On (b)(6) 2018 it was reported that the patient was still inpatient and stable on inotropes. Review of the submitted log file by technical services revealed lvad flow trending downward over time. The lvad speed was changed between 7600 rpm ¿ 9000 rpm. The low flow alarms were reportedly increasing in frequency. On (b)(6) 2018 the patient underwent heart transplant after being upgraded on the transplant list from 1b to 1ab due to outflow graft twisting. The patient¿s heart was explanted with heartmate 3 attached to the left ventricle. The surgeon cut into the bend relief exposing the outflow graft with a visible twist just superior to the blue screw ring. It was reported that the blue screw ring was loose and able to be rotated left and right with slight effort. On 29may2018, it was reported that the patient was so far stable after transplant. No further information was received.
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Manufacturer (Section D)
6035 stoneridge drive
pleasanton CA 95488
Manufacturer (Section G)
6035 stoneridge drive
pleasanton CA 95488
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
MDR Report Key8088799
MDR Text Key127864206
Report Number2916596-2018-05205
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 06/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/05/2019
Device Catalogue Number106524
Device Lot Number6125820
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/17/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberFA-Q118-MCS-1

Patient Treatment Data
Date Received: 11/20/2018 Patient Sequence Number: 1