MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM; VENTRICULAR (ASSIST) BYPASS

Model Number 106524US

Device Problems Device Difficult to Setup or Prepare (1487); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Air Embolism (1697); Bacterial Infection (1735); Stroke/CVA (1770); Infarction, Cerebral (1771); Unspecified Infection (1930); Neurological Deficit/Dysfunction (1982); Coma (2417); Multiple Organ Failure (3261)

Event Date 06/25/2019

Event Type  Injury  

Manufacturer Narrative

Approximate age of device- 1day.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) 2019.It was reported that patient was implanted with a heartmate 3.Nothing unusual noted regarding pump prep or placement.Device started at 3000 rpms and patient weaned off bypass.Over approximately 10 minutes the pump was increased to 5000 rpms.Initially patient and device parameters were stable.It was noted that a large amount of air appeared in the lv (via echo).At the same time, the flow on the lvad decreased significantly to around 0.5 lpm, and the patient was placed back on bypass.Once stable on bypass, a source for the air was looked for but nothing presented itself.No signs of bleeding around the lvad or other cannulas in the heart.Lvad restarted and similar startup procedure followed (taking a little more time with speed increases).Again, at 4800 rpms, a large amount of air appeared in the lv and around the inflow cannula, and flows decreased to around 0.5 lpm.It appeared on echo as if the air was coming from the lvad into the lv.The decision was made to replace the pump.When removing the lvad from the heart, it was noted that the yellow lines on the cuff lock were slightly visible.The surgeon reengaged the cuff lock, but the pump was able to swivel freely on the apical cuff despite being locked in place.The pump was removed and compared with the newly opened pump.The locking arms on the cuff lock were not symmetrical whereas the new pump they were.With the new pump in place the device was started and again the patient weaned off bypass.This time there were no issues and no air visualized once speeds achieved at 5000 rpms.Pt settled at 5200 rpms with stable hemodynamics and lvad parameters.

Manufacturer Narrative

Section h3: corrected information.Section h8: additional information.Manufacturer's investigation conclusion: the report of the cuff lock arms being asymmetrical was confirmed during the evaluation of the pump.The pump was returned assembled with the cuff lock seated in the default position.Visual inspection of the cuff lock found that one of the locking arms appeared bent outward toward the locked position.The cuff lock moved freely upon manipulation and could not be forced into the locked position with no apical cuff in place, as intended by design.The o-ring that seals the interface between the inflow cannula and the apical cuff was present and appeared free of damage or defect.Review of the log file retrieved from the pump confirmed the reported decrease in flow.Measurements taken of the cuff lock confirmed that the left arm was bent out of specification.Review of manufacturing documentation, which includes measurements, functional testing, and visual inspection of the cuff lock for bent arms found no deviations in manufacturing or quality assurance specifications.The cuff lock was reassembled and a test apical cuff was connected.The cuff lock engaged easily and without issue.The pump did not feel loose when rotated within the cuff, even when the connection was lubricated with saline.The evaluation was unable to determine when or how the cuff lock arm became bent out of specification.A direct correlation between the bent arm and the reported air entrainment could not be determined.However, it was reported that the yellow indicators were found to be visible following the entrainment and an incomplete sealing of the connection could have contributed to the issue.The remainder of the device appeared unremarkable.Examination of the blood-contacting surfaces found no depositions or defects.The pump was reassembled and operated on a mock circulatory loop and functioned as intended in accordance with manufacturing specification.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

Patient death is reported under mfr#: 2916596-2019-03564.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that a head computed tomography (ct) scan revealed multiple cerebral infarctions resulting from massive air emboli during surgery, and the patient's post operative course was complicated by epilepticus, bilateral cerebral infarcts, neurologic compromise, systemic infection, severe brain injury, multi-organ failure, and a persistent vegetative state (persistent comatose state also noted).The patient expired on (b)(6) 2019.

Event Description

It was reported through the research article "air embolism following implantation of a heartmate 3 pump¿ a 67-year-old man with refractory systolic heart failure secondary to ischemic cardiomyopathy underwent implantation of the heartmate 3 (hm3) device in the standard fashion through a median sternotomy.The pump was started and set to 5,000 rpm with acceptable hemodynamics.Echocardiography demonstrated appropriate positioning with complete resolution of intracardiac air.A few minutes after protamine was administered, the ascending aorta was noted to be filled with air on echocardiography, prompting emergent placement back on bypass and needle tack vent placement in the ascending aorta.The aorta and left ventricle (lv) were de-aired on bypass, and a corrective air emboli protocol was initiated.Following optimization, subsequent attempts to wean off bypass and ramp up the device resulted in the same large air bolus recurring each time with opacification of the lv and ascending aorta.During the fourth attempt, air was observed entering the lv from around the inflow cannula.The apex of the heart was elevated and it was noted that the device could rotate freely while clasped to the apical connector ring, which is abnormal.Following device removal, the underside was examined and the left clasp was noted to be distracted away from the inflow cannula and did not appear attached to the pin.It was further observed that moving the fastening pin did not result in a tight seal around the inflow cannula.A new hm3 device was opened and compared with the initial device.The new device had both clasps oriented toward the midline and was placed onto the apical connector without difficulty with pin engagement.Once engaged, it was noted that it would not freely rotate in place.The rest of the operation was completed, and when the device speed was ramped, there was no entrainment of air in the lv.The patient was transferred to the critical care setting but experienced seizures and massive watershed embolic infarcts because of air emboli.Subsequently, care was withdrawn.

Manufacturer Narrative

Section b5: author: (b)(6) article title: air embolism following implantation of a heartmate 3 pump manufacturer's investigation conclusion: the report of the cuff lock arms being asymmetrical was confirmed during the evaluation of (b)(6).The pump was returned assembled with the cuff lock seated in the default position.Visual inspection of the cuff lock found that one of the locking arms appeared bent outward toward the locked position.The cuff lock moved freely upon manipulation and could not be forced into the locked position with no apical cuff in place, as intended by design.The o-ring that seals the interface between the inflow cannula and the apical cuff was present and appeared free of damage or defect.Review of the log file retrieved from the pump confirmed the reported decrease in flow.Measurements taken of the cuff lock confirmed that the left arm was bent out of specification.Review of manufacturing documentation, which includes measurements, functional testing, and visual inspection of the cuff lock for bent arms found no deviations in manufacturing or quality assurance specifications.The cuff lock was reassembled and a test apical cuff was connected.The cuff lock engaged easily and without issue.The pump did not feel loose when rotated within the cuff, even when the connection was lubricated with saline.The evaluation was unable to determine when or how the cuff lock arm became bent out of specification.A direct correlation between the bent arm and the reported air entrainment could not be determined.However, it was reported that the yellow indicators were found to be visible following the entrainment and an incomplete sealing of the connection could have contributed to the issue.The remainder of the device appeared unremarkable.Examination of the blood-contacting surfaces found no depositions or defects.The pump was reassembled and operated on a mock circulatory loop and functioned as intended in accordance with manufacturing specification.The relevant sections of the device history records were reviewed and showed no deviations from mfg or qa specifications.The implant kit shipped on 4/28/2019.Heartmate 3 lvas ifu provides instructions on all surgical procedures, including preparing the ventricular apex site and inserting the pump in the ventricle.The ifu cautions that after the apical cuff has been sewn to the heart, the metal ring on the apical cuff should extend above the felt surface to allow proper engagement and locking with the slide lock of the heartmate 3 lvad.Ensure that apposition between the myocardial tissue and the cuff felt is continuous and sufficiently forceful to prevent bleeding.If the slide lock mechanism on the hm3 lvad fails to engage, do not make further attempts to engage until retracting the slide lock mechanism.Evidence of slide lock mechanism failing to engage will be either visual evidence of the yellow ¿wings¿ or a tactile feel of three ridges versus one.The slide lock will not engage the apical cuff unless initially fully retracted.If difficulty persists when engaging the slide lock mechanism, the lvad should be removed from the apical cuff to visualize what might be preventing the connection.The suture knots should not interfere with the connection.If a sealing agent is used on or near the apical cuff, it should not interfere with the slide lock mechanism.The surgical procedures section also includes information on de-airing the pump.During the implant process, a complete backup system (implant kit and external components) must be available on-site and in close proximity for use in an emergency.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 8767642
• MDR Text Key: 150275047
• Report Number: 2916596-2019-03141
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 6944578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/25/2019
• Initial Date FDA Received: 07/08/2019
• Supplement Dates Manufacturer Received: 07/31/2019; 12/03/2020; 06/30/2022
• Supplement Dates FDA Received: 08/06/2019; 12/23/2020; 07/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 79 KG