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

Catalog Number 104911

Device Problems Device Stops Intermittently (1599); Incorrect Device Or Component Shipped (2962)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/16/2016

Event Type  malfunction  

Manufacturer Narrative

Device unique identifier (udi) ¿ device was manufactured prior to the udi labeling implementation.Approximate age of device ¿ 3 years, 1 month.The replaced external portion of the percutaneous lead (lead) was returned for analysis.The report of driveline fault alarms, red heart alarms, and pump stop events was confirmed based on the evaluation of the returned lead.Continuity testing was performed which found an issue in the green wire.The lead¿s silastic sleeve was removed, and examination of the shielding and bionate revealed areas with shield breakdown.The green wire was fractured adjacent to the metal/system controller connector and the conductors of the green wire were exposed.Further examination of the remaining wires in this area revealed marks consistent with abrasion.The fracture of the green wire appeared to be the result of repetitive flexing of the lead in this area.There was no evidence of mechanical damage such as crushing or pinching.The pump operates on a three phase motor, where each phase is powered by two redundant wires.The system controller monitors the current in each redundant wire pair to detect open circuit conditions.When the current in the green wire was compared to that of its redundant motor phase wire, the fractured inner conductors would have resulted in the reported driveline fault alarms.Function would have also been interrupted if the fractured green wire¿s exposed conductors had contact with the braided shield.If the device was being supported by the power module at that time a short to ground would occur resulting in the reported low speed and pump stop events.The system controller log files reviewed confirmed the occurrence of driveline fault alarms, low speed/low flow hazards, and pump stop events.The events captured in the log files appeared to occur while the patient was supported by the power module and patient cable.X-rays of the patient's internal and external portions of the percutaneous lead were reviewed but no areas with shield breakdown were noted.The patient remains on lvad support.A review of the device history records revealed that the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.

Event Description

The patient was implanted with a left ventricular assist device (lvad).It was reported that the patient received an audible and visual driveline fault alarm while at home.The patient presented to the clinic and a system controller exchange was performed, however, the driveline fault alarm reoccurred.Low speed events and pump stoppages occurred while the patient was supported on the power module and could be recreated upon manipulating the external portion of the patient's percutaneous lead.After being placed on battery power, the alarms ceased and the patient remained asymptomatic and was reportedly stable.The patient was admitted for suspected external percutaneous lead fracture.Log files were reviewed by the manufacturer's technical services representative and appeared consistent with an issue with the percutaneous lead.X-rays were found to be unremarkable.On (b)(6) 2016, the manufacturer's technical services representative performed an onsite evaluation of the patient's percutaneous lead and no open wires were found.The full external portion of the percutaneous lead was replaced.All testing of the new percutaneous lead passed.No further issues were reported.

• 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: 5499597
• MDR Text Key: 40302573
• Report Number: 2916596-2016-00460
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2014
• Device Catalogue Number: 104911
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/13/2012
• 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 Age: 64 YR
• Patient Weight: 111