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Model Number 106524INT
Device Problem Partial Blockage (1065)
Patient Problem Thrombus (2101)
Event Date 05/03/2018
Event Type  Injury  
Manufacturer Narrative
Approximate age of device ¿ the day of implant. The device is expected to be returned for analysis. It has not yet been received. The patient remains ongoing on lvad support with the replacement device. 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 a left ventricular assist device (lvad) on (b)(6) 2018. It was reported that during implant, the patient had massive scarred myocardial tissue due to an infarction that had occurred in january prior to lvad implant. The ventricular wall was very thin. After coring, the surgeons noticed sclerotic material inside the left ventricle. The implant continued after remediating the whole cavum of the left ventricle. Just before closing the chest, the pump flow dropped suddenly and pump power decreased. Echocardiography showed no signs of influential flow above the inflow cannula. A severe inflow occlusion was suspected. The patient was hemodynamically stabilized with high dose catecholamines and volume loading. The patient was placed back on the heart lung machine. The lvad was stopped and the pump was removed. A large sclerotic formation was found inside the inflow cannula. The pump was exchanged, and the apical cuff and outflow graft were left in place. Subsequently, the patient was stabilized with reduced catecholamines and transferred to the intensive care unit. No additional information was provided.
Manufacturer Narrative
The report of thrombus in the inflow cannula was confirmed through the evaluation of the submitted images; however, the evaluation of heartmate 3 lvas did not reveal any device-related issues. The evaluation of the submitted controller event log file revealed that following implant, the pump appeared to operate with the calculated flow ranging between 2. 1 and 4. 3 lpm. Transient low flow fault flags were observed during this period of time, associated with the calculated flow reaching values below the low flow threshold of 2. 5 lpm. Subsequently, the calculated flow decreased to 0. 0 lpm, and a constant low flow hazard alarm was observed. The calculated flow then ranged between 0. 0 and 1. 0 lpm until the pump was disconnected and the controller was powered down. The account submitted images for evaluation. The first image presented several pieces of tissue. It was reported that these pieces of tissue were sclerotic material removed from the left ventricle prior to the implant of the device. The second image depicted one piece of tissue, which was similar in appearance to the sclerotic material observed in the first image. It was reported that this formation was observed in the inflow cannula of the heartmate 3 lvas after the pump was stopped and removed. Upon disassembly of the returned pump, examination of the blood-contacting surfaces revealed no developed depositions or thrombus formations that would have contributed to the reported event. Visual inspection of the pump rotor and rotor well did not reveal any obvious surface scratches or defects. The pump was cleaned, rebuilt, and functionally tested on a mock circulatory loop. The device operated as intended and in accordance with manufacturing specifications. Thrombus is listed in the instructions for use (ifu) 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, including the sterilization and packaging documentation, found no deviations from manufacturing specifications. The manufacturer is closing the file on this event.
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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 Key7548877
MDR Text Key109387231
Report Number2916596-2018-02036
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
Type of Report Initial,Followup
Report Date 07/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2020
Device Model Number106524INT
Device Catalogue Number106524INT
Device Lot Number6238691
Other Device ID Number00813024011712
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/19/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/06/2017
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: 05/29/2018 Patient Sequence Number: 1