MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS; LEFT VENTRICULAR ASSIST DEVICE

Catalog Number 106015

Device Problems Use of Device Problem (1670); Cut In Material (2454)

Patient Problems Chest Pain (1776); Low Blood Pressure/ Hypotension (1914)

Event Date 08/02/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Approximate age of device - 4 months.The distal portion of the driveline that was accidentally cut/severed by the patient was returned for analysis.The evaluation is not complete.The patient remains on lvad support.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.It was reported that the patient presented to the implanting center with a severed driveline.The patient reported that the driveline was accidentally severed while using scissors to cut tape.The patient was in stable condition at that time without inotropic support.The facility reported not having a surgeon available at the time for a pump exchange, so the decision was made to transfer the patient to another implanting center for further evaluation and management.The patient was transferred to another implanting facility approximately 4 hours away.The patient was admitted to the icu in stable condition on milrinone and heparin infusions.The length of time the pump had been off from when the driveline was severed was unknown.The attending physician requested an assessment of the patient's driveline and possible attempt of an external repair of the driveline.At that time, the patient was symptomatic with hypotension and chest pain.On (b)(6) 2015, the following day, the manufacturer's technical services and clinical representatives assessed the driveline which was found to have all conductors cut in half with a strand of the strength member still intact.The patient was alert, talking and sitting up in bed.Per the physician's request, an external driveline replacement was performed.After completion of the repair, the driveline remained disconnected from the system controller per the physician's instructions.On (b)(6) 2015, the pump remained disconnected from the system controller and the patient remained stable.On (b)(6) 2015 it was reported that after unspecified testing and discussion among the surgical and medical teams, it was determined that no clots were present in the patients inflow cannula or outflow graft.Based on this data, the pump was restarted utilizing echocardiogram guidance.The left ventricular end diastolic diameter (lvedd) was determined to be 6 cm prior to starting the pump.Upon achieving the fixed speed of 9200 rpm, the lvedd was approximately 4.5 cm.The pump speed was ramped up and suction was achieved at approximately 11000 rpm.The pump was then returned to the patient's baseline setting of 9200 rpm at the completion of the ramp test.The patient denied any untoward distress, other than a little lightheadedness when the pump was set at 11000 rpm.The patient will remain under observation and for correction of anticoagulation.The patient was given 10 mg of coumadin in the evening along with bridging with heparin.No further events have been reported.

Manufacturer Narrative

The manufacturer was unable to conduct an investigation of the device as the patient remains on going with the implanted device.The reported event of a severed driveline was confirmed by an onsite evaluation by the manufacturer and submitted photo.In addition, the log file evaluation confirmed pump stops and driveline disconnects events consistent with the reported severance of the driveline.A section of the driveline, approximately 18¿ from the connector was returned for evaluation.No damage to the silicone sleeve was observed.The silicone sleeve was removed.Electrical continuity testing of the returned portion of the driveline did not reveal any discontinuities or shorts prior to removing the bionate.No damage to the bionate was observed.The bionate was removed and no damage to the metal shielding was observed.The metal shielding was removed.Visual inspection of the wire found no fracture or breach.The driveline was submerged in a saline bath for hipot testing to check the resistance of each wire's insulation.The test did not reveal any current leakage in the insulation of any of the wires that would have resulted in an electrical short.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LVAS
• Type of Device: LEFT VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: robert fryc ; 23 fourth avenue; burlington, MA 01803 ; 781272-013
• MDR Report Key: 5041256
• MDR Text Key: 24518662
• Report Number: 2916596-2015-01586
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Report Date: 08/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: 106015
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 73