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Catalog Number 106524
Device Problems Partial Blockage (1065); High Readings (2459); Material Deformation (2976)
Patient Problems Hemolysis (1886); Thrombus (2101)
Event Date 02/05/2018
Event Type  Injury  
Manufacturer Narrative
The initial submission of this event was reported by the manufacturer under mfr report # 2916596-2018-00779. This report is being submitted as additional information. The heartmate 3 lvas was implanted during the momentum 3 (short term, cap, or long term) 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 heartmate 3 lvas is (b)(4). Approximate age of device ¿ 1 year and 11 months. Manufacturer investigation conclusion: the pump remains implanted and the patient continues on vad support. Although the surgeon noted that the outflow graft was twisted during the surgical procedure, no photographs were provided and the product was not returned, therefore a direct correlation between heartmate 3 left ventricular assist system (lvas) and the reported outflow graft twist could not conclusively be established through this evaluation. Additionally, the reported thrombus, elevated ldh, static sounds coming from the vad and bleeding could not conclusively be established through this evaluation. Analysis of the submitted system controller log file confirmed low flow alarms; however, a specific cause for this finding could not be conclusively determined through this evaluation. The submitted system controller event and system controller periodic log files contained data ranging between (b)(6) 2018 at 2:50:19 am to (b)(6) 2018 at 7:10:56 am and (b)(6) 2018. On (b)(6) 2018, intermittent low flow hazard alarms were noted throughout the history file. On (b)(6) 2018, intermittent low flow alarms were and continued until 2:31:46 am. Afterwards, a constant low flow hazard alarm was observed for the remainder of the file. No atypical alarms were captured within the log files. The submitted lvad log files was noted to captured low flow events. The pump speed remained above the low speed limit and the pump appeared to function as intended. It was also mentioned that the vad sounded like it was working hard and static. The heartmate 3 lvas ifu lists thromboembolism, lvad flow obstruction, bleeding and hemolysis as potential risks that may be associated with the use of the device. The ifu 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. This ifu also describes the pump flow display and the hazard alarms. The low flow hazard alarm will be triggered when pump flow is less than 2. 5 lpm, and changes in the patient¿s condition can result in low flow. This ifu and the heartmate 3 lvas patient handbook describe the actions to take in the event of a low flow alarm. The ifu also provides information regarding anticoagulation, including recommended inr values and the suggested anticoagulation modifications in the event that there is a risk of bleeding. Lastly, this document instructs the user to notify appropriate personnel if there is a change in how the pump works, sounds, or feels. Abbott has decided to initiate a voluntary field action for all lot numbers of heartmate iii distributed since september 2014. Internal investigation performed by abbott has determined there is a potential for an outflow graft occlusion due to twisting. Abbott performed a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis. The root cause identification determined that bend relief rotation is inconsistently translated to the outflow graft hardware. A risk/benefit analysis was performed and it was determined that despite the potential for an outflow graft occlusion due to twisting, the associated residual risks are low and are considered acceptable. As a corrective action, consignees have been notified of the potential occlusion due to twisting. Additionally, abbott will continue to trend complaints related to this event based on original event description and/or results of product evaluation. No further information is available. The manufacturer is closing the file on this event.
Event Description
It was reported that the patient was admitted due to lvad low flow alarms. The patient¿s lactate dehydrogenase (ldh) was elevated upon admission. It was suspected that there was a clot in the pump. The patient was taking the anticoagulant aspirin at the time of the event. Lvad speed was increased from 5300 rpm to 5600 rpm. Per technical service¿s review of the log file, this increase in speed did not appear to have had much effect on the lvad flow. It was observed within the log file that the flow began trending downward on (b)(6) 2018. The patient¿s central venous pressure (cvp) was 26 mmhg. An echocardiogram (echo) was completed; results were not provided. The patient was started on dobutamine, epinephrine (epi) and nitrous oxide (no). Reportedly the vad sounded like it was working hard. The patient was provided 2 doses of tissue plasminogen activator (tpa). The low flow alarm was reported as continuous. A clot in the proximal outflow cannula and possible 180 degree twist in the outflow graft was noted on ct scan. The filling defect in the proximal outflow cannula, consistent with thrombosis, resulted in approximately 50% focal stenosis. Diffuse pulmonary parenchymal heterogeneity resulting from either pulmonary edema in the setting of cardiomegaly with low cardiac output or small airways inflammation was also observed. On (b)(6) 2018, tpa dose number 5 was provided to the patient. The patient was taken to the operating room on (b)(6) 2018 for exploration and surgical outflow correction. A subcostal incision was made over the outflow graft and the bend relief was disengaged. The outflow graft was found to be twisted counter clockwise. After the outflow graft was untwisted, lvad flows and the patient¿s overall condition improved. No additional information was provided. It was reported that on (b)(6) 2018 the patient developed post-operative anemia following the surgical procedure on (b)(6) 2018 to repair the outflow graft. The patient¿s hemoglobin and hematocrit (h&h) remained low following the surgery. On (b)(6) 2018 the patient was transfused 1 unit packed red blood cells (prbcs) with an h&h of 7. 0 g/dl and 22. 4% respectively. The patient developed a transfusion reaction. H&h the following day was 6. 9 g/dl and 21. 9%. On (b)(6) 2018 the patient received 1 unit prbcs. The following day h&h was 7. 6 g/dl and 24. 5%. No signs of bleeding were noted and the anemia reportedly resolved on (b)(6) 2018. The patient was on the anticoagulants aspirin, warfarin, and heparin at the time of the 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 Key8253898
MDR Text Key133253346
Report Number2916596-2019-00206
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
Report Date 01/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2016
Device Catalogue Number106524
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/28/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/17/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1774-2018

Patient Treatment Data
Date Received: 01/16/2019 Patient Sequence Number: 1