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Model Number 106524INT
Device Problems Partial Blockage (1065); Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/25/2018
Event Type  Injury  
Manufacturer Narrative
The initial submission of this event was reported by the manufacturer under mfr. Report # 2916596-2017-02238. This report is being submitted as additional information. Approximate age of device ¿ 18 days. Previous manufacturer's investigation conclusion submitted under mfr. Report # 2916596-2017-02238: the report of low flow alarms was confirmed through the analysis of the submitted system controller log files. The submitted log files contained data from (b)(6) 2017 at 14:27:48 to (b)(6) 2017 at 08:20:22. No hazard alarms were captured until (b)(6) 2017 at 07:44:38 when the low flow hazard alarm became active. This alarm remained active throughout the remainder of the log file with a calculated average flow rate of 0 lpm. Although the reported low flow alarms were confirmed, a specific cause for the alarms could not conclusively be determined through this evaluation as the submitted log files appeared to show the pump functioning as intended. Furthermore, a direct correlation between the device and the patient's fall could not conclusively be established. It was reported that the device was working as expected during that event. Stroke and bleeding are listed in the instructions for use as potential adverse events that may be associated with the use of the heartmate 3 left ventricular assist system. A review of the device history records revealed no deviations from manufacturing or quality assurance specifications. Device analysis (additional information): a correlation between the evaluation of the pump and the previously reported sudden drop in flow cannot be conclusively determined as the device was explanted approximately 1 year after it was turned off. Upon disassembly of the returned pump, depositions of tissue admixed with coagulated blood were observed in the inflow cannula, outflow graft, on the rotor, and in the pump cover. All of the depositions found in the evaluation of the pump appeared to have developed as a result of poor surface washing due to a low flow event or interruption in flow through the pump consistent with the report that the device was turned off following a sudden decrease in flow down to 0 lpm. The device was cleaned, rebuilt, and tested under load conditions on a mock circulatory loop. The pump functioned as intended. Thromboembolism is listed in the instructions for use as a potential adverse event that may be associated with the use of the heartmate 3 left ventricular assist system. A review of the device history records revealed the device met applicable manufacturing 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 one day post-implant, the patient fell and hit their head while going to the restroom. The patient developed a small intracranial bleed and anticoagulation was stopped completely for 24 hours, after which low dose heparin was initiated. No lvad issues were reported and the device was reportedly working as expected during this event. On (b)(6) 2017, approximately 18 days post-implant and 17 days after the patient fell, sudden low flow alarms occurred with calculated pump flows of 0. 0 lpm. The alarms were confirmed via the system controller log files. Ct angiography showed no flow through the pump. The neurosurgical physicians recommended to wait an additional 2 weeks before another heart surgery with a heart lung machine could take place. Therefore, the vad healthcare professionals decided against surgical intervention / pump exchange at the time. As there were contraindications for surgery, the physicians decided to stop the pump by disconnecting it from the system controller. The patient was reportedly stable with the pump stopped. Additional information: it was reported that the patient received a heart transplant on (b)(6) 2018. No additional information was provided.
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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 Key8067260
MDR Text Key127057794
Report Number2916596-2018-04896
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2020
Device Model Number106524INT
Device Catalogue Number106524INT
Device Lot Number6031577
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/07/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/22/2017
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: 11/13/2018 Patient Sequence Number: 1