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

Catalog Number 106015

Device Problem Cut In Material (2454)

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

Event Date 02/02/2018

Event Type  malfunction  

Manufacturer Narrative

Device unique identifier (udi) ¿ device was manufactured prior to the udi labeling implementation.Approximate age of device ¿ 3 years and 3 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) 2014.It was reported that the percutaneous lead (driveline) extending from the patient¿s abdomen to the system controller was missing silastic and the inner driveline was exposed.There was also a separation from where the silastic met the metal connection to the system controller.The patient presented with tape applied to the driveline.Interrogation found no alarms.Replacement of the outer portion of the driveline was requested due to concern of the exposure of the inner driveline and to prevent any adverse events.On (b)(6) 2018, technical services performed a distal end driveline replacement without issue.Post replacement the lvad was placed on a regular grounded patient cable.The patient was to be discharged to home.

Manufacturer Narrative

The evaluation of the returned portion of the driveline (dl) confirmed the reported cosmetic damage to the silicone sleeve.A distal end driveline repair was performed by a technical services representative on (b)(6) 2018.The approximately 19-inch segment of driveline replaced by technical services was returned for evaluation.Electrical continuity testing did not reveal any discontinuities or shorts.Visual inspection of the wires did not reveal any breaches or areas of concern.The driveline 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.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: 7304454
• MDR Text Key: 101527193
• Report Number: 2916596-2018-00764
• 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: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: 106015
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 112