MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS); VENTRICULAR (ASSISST) BYPASS

Model Number 106016

Device Problems Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Death (1802); Edema (1820); Ischemia (1942); Loss of consciousness (2418); Cerebral Edema (4403)

Event Date 09/06/2020

Event Type  Death  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that patient with limited pump flow was connected to extracorporeal membrane oxygenation (ecmo).Patient was admitted to the hospital with ionotrope support, and va ecmo initiated.During hospitalization at (b)(6), the patient had a consciousness disorder.A ct angiographic examination of the brain and cerebral arteries did not show acute changes.In echocardiographic examination, lvad dysfunction was suspected.The patient was transferred to the resuscitation ward - ventilatory support, pharmacological circulatory support, introduced ecmo, followed by stabilization of the blood circulation.A repeated ct and neurological examination demonstrated the development of cerebral ischemia and cerebral edema with an infaust prognosis established by a neurologist - followed by terminal weaning.The patient passed away on (b)(6) 2020.

Manufacturer Narrative

Manufacturer's investigation conclusion: incidental findings: superficial driveline damage.A direct correlation between heartmate ii lvas, serial number (b)(4), and the reported events could not be conclusively established through this evaluation.The report of low flow alarms was confirmed via the submitted log files.According to the account, the low flows were due to the patient's deteriorated clinical condition.The account submitted log file for review.Analysis of the submitted log file revealed multiple low flow hazard alarms were captured throughout the log file when the flow dropped below the 2.5 lpm threshold.The pump remained above the low-speed limit and appeared to be functioning as intended.The account communicated that the patient was admitted to the hospital with ionotrope support, and veno-arterial (va) extracorporeal membrane oxygenation (ecmo) was initiated.During hospitalization, the patient had a consciousness disorder.A ct angiographic examination of the brain and cerebral arteries were performed and did not show acute changes.The patient was transferred to the resuscitation ward with ventilatory support, pharmacological circulatory support, introduced ecmo, and followed by stabilization of the blood circulation.A repeated ct and neurological examination demonstrated the development of cerebral ischemia and cerebral edema with an infaust prognosis established by a neurologist followed by terminal weaning.The patient ultimately expired due to multiple organ dysfunction syndrome (mods) related to malignant brain edema.Vad-59913 was returned assembled with driveline intact (figure 1).All parts of the inflow conduit (the inlet tube, inflow conduit flex section, and inlet elbow) were returned.The inlet elbow was attached to the pump.The outflow conduit was returned attached to the pump outlet housing.The bend relief collar was also present.Upon disassembly of the returned device, depositions of tissue-like clotted blood were observed on the interior of the outflow graft and the proximal side of the outflow elbow.Also, a tissue-like material was observed on the proximal side of the proximal sides of the outlet stator.These depositions appear consistent with an interruption in flow; however, a specific cause for this period of low flow could not be conclusively determined through this evaluation.Upon removal of the observed deposition, the device was cleaned.The pump's bearings, rotor, and blood-contacting surfaces were then examined under a microscope and no anomalies were observed.Electrical continuity testing of the driveline revealed no discontinuities or shorts.The pump was reassembled and functionally tested under normal operating conditions using a mock circulatory loop.The data retrieved from that testing revealed normal pump power consumption and pressure values, comparable to what was recorded during the manufacturing process and the device functioned as intended.The relevant sections of the device history records for (b)(4) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit shipped on 23dec2015.The hmii lvas ifu lists device thrombus, stroke, and death as adverse events that may be associated with the use of the heartmate ii left ventricular assist system and provides information regarding the recommended anticoagulation therapy and inr range.The ifu explains that pump flow is estimated from the pump power and pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling.The low flow alarm is triggered when the flow is less than 2.5 lpm.Section 6 outlines indications of pump thrombosis, as well as how to respond to such events.Furthermore, the ifu describe all alarm conditions, including the low flow hazard alarm, as well as the appropriate actions associated with each condition.The hmii lvas ifu and patient handbook contain sections on ¿caring for the driveline,¿ and explain that all heartmate ii lvad drivelines have the potential for breakdown to occur dependent upon length of use and patient handling.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Additional information received on 31dec2020 states that low flow was related to patient's deteriorated clinical condition.The low flows did not resolve, and extracorporeal membrane oxygenation (ecmo) support was initiated.The patient expired under picture of multiple organ dysfunction syndrome (mods) related to malignant brain edema.It was unknown if the device operated as expected.

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

• Brand Name: HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 11088245
• MDR Text Key: 224086402
• Report Number: 2916596-2020-06464
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2018
• Device Model Number: 106016
• Device Catalogue Number: 106016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization