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

Catalog Number 104911

Device Problem Cut In Material (2454)

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

Event Date 01/31/2018

Event Type  malfunction  

Manufacturer Narrative

Device unique identifier (udi) ¿ device was manufactured prior to the udi labeling implementation.Approximate age of device ¿ 4 years and 8 months.The patient remains ongoing on lvad support; however, a portion of the percutaneous lead was received for investigation.The evaluation is not yet complete.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) 2013.It was reported that a percutaneous lead repair was requested due to cosmetic damage.On 06feb2018, technical services performed distal end percutaneous lead (driveline) replacement without issue.The lvad was placed on regular grounded patient cable post replacement.The patient was to be released to home.

Manufacturer Narrative

The percutaneous lead was tested for electrical continuity in the condition that it was received and did not reveal any discontinuities or shorts.Examination of the percutaneous lead noted several tears under the rescue tapes.However, the underlying bionate was free of damage.Upon removal of the silicone sleeves, overall metal braided shield deterioration was noted.In addition, a minor kink was observed approximately 15 inches from the metal connector.The silicone jacket, clear bionate, and metal braided shield were removed in order to examine the underlying wires.Visual inspection of the percutaneous lead did not reveal any evidence of mechanical damage or breakdown of the wire insulation.The percutaneous lead was submerged in a saline bath for high-potential testing to check for current leakage through each wire's insulation.The test did not reveal any insulation breaches that would have contributed to an electrical short.The patient was placed on regular grounded patient cable post repair and discharged.The patient remains ongoing on the left ventricular assist system (lvas) and no further related issues have been reported.A review of the device history records revealed no deviations from manufacturing or quality assurance specifications.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: bob fryc ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 7818528390
• MDR Report Key: 7301371
• MDR Text Key: 101347475
• Report Number: 2916596-2018-00725
• 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,Followup
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2015
• Device Catalogue Number: 104911
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2013
• 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: 76 YR
• Patient Weight: 76