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

Catalog Number 104911

Device Problems Cut In Material (2454); Material Deformation (2976)

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

Event Date 07/01/2015

Event Type  malfunction  

Event Description

The patient was implanted with a left ventricular assist device (lvad).It was reported that the patient was admitted to the hospital due to volume overload.It was reported that the patient had progressive deterioration of his percutaneous lead (lead), but was unable to keep his appointments with the clinic.The system controller data log file was submitted to the manufacturer for evaluation along with pictures and x-ray images of the lead.The analysis of the log file revealed a few transient power level increases.The pictures of the lead were examined and showed a large amount of tape of various types covering the lead.The x-ray images showed abnormal kinking of the lead.No abnormal pump operation was observed at the time of the analysis and a distal-end replacement of the lead was scheduled to prevent future failure.During the distal-end lead replacement, the evaluation of the lead revealed a slit in the braided shield near the lead¿s exit site from the patient.The observed compromise to the shield appeared to affect its ability to sustain a ground.This appeared to be the most likely reason why the patient did not receive any alarms.The distal-end replacement of the lead was completed successfully and subsequent issues have been reported.

Manufacturer Narrative

Approximate age of device - 4 years.The replaced portion of the percutaneous lead was received for investigation.The evaluation is not yet complete.The patient remains ongoing with the implanted device.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Manufacturer Narrative

The evaluation of the returned percutaneous lead (lead) confirmed the report of superficial lead damage.Approximately 17 inches of the external portion/distal end of the lead was returned for evaluation.Large amounts of tape were applied to the entire length of the lead.The tape and reinforcing sleeve were removed, and examination of the shielding and bionate layers revealed areas with shield breakdown, and multiple kinks and twists.Continuity testing was performed on the returned portion of the lead and no issues were found.The shielding and bionate layers were removed and examination of the underlying wires revealed disruptions in the insulation of the green wire approximately 3 inches from the metal system controller connector, and in the insulation of the black wire, approximately 10.5 inches from the metal system controller connector.As a result, the conductors of these wires were exposed.The disruptions of the wires appeared to be the result of mechanical damage, as a result of the large amounts of kinking and twisting.The disruptions in the wires could have interrupted function as a result of the exposed conductors of either the green or black wires potentially contacting the braided shield and creating an electrical short to ground if the device was supported by the power module.The electrical short to ground would have caused alarms and low speed events; however, due to the kinking and twisting of the lead, the braided shielding had deteriorated in some areas, and there might not have been a connection to sustain a ground to cause any alarm.A review of the device history records revealed no deviations from manufacturing or quality assurance specifications.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LVAD
• 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: 4962701
• MDR Text Key: 6319761
• Report Number: 2916596-2015-01400
• 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: User Facility,Company Representative,company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2013
• Device Catalogue Number: 104911
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/17/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 78