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 Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/28/2016

Event Type  malfunction  

Manufacturer Narrative

Device unique identifier (udi) ¿ device was manufactured prior to the udi labeling implementation.Approximate age of device ¿ 2 years, 6 months.The pump remains in use supporting the patient; however, a portion of the driveline 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).It was reported that the patient presented to the hospital after accidentally slamming the driveline in a door.The white silastic covering was torn and the black wire covering was damaged.The damaged area was covered with rescue tape.The patient was reported to have been asymptomatic.The manufacturer's technical services reviewed the provided log file and confirmed there were no pump stoppages.On (b)(6) 2016, an onsite external driveline repair was completed and the damaged area was removed.

Manufacturer Narrative

The reported damage to the patient''s driveline was confirmed based on the submitted driveline photo and the evaluation of the returned section of the driveline.A section of the external portion/distal end of the driveline approximately 21 inches was returned.Electrical continuity test of the driveline in its returned condition was conducted and all wires were found to be electrically intact.No wire-to-wire or wire-to-shield shorts were induced during this testing, even with manipulation of the driveline.The driveline had large amounts of rescue tape applied to majority of its areas and after the tape was removed, the reported damage to the silastic sleeve, bionate layer, and shielding was confirmed.The remaining portions of the silastic sleeve were removed, and examination of the bionate layer and shielding revealed areas with shield breakdown.The bionate layer and shielding were removed to examine the underlying wires.No evidence of wear or damage to the wires was found.The driveline was submerged in a saline bath for high potential testing to check for a current leakage through each wire¿s insulation.The test revealed that all of the wires appeared unremarkable and passed all continuity and high potential testing.A review of the device history records showed no deviations from manufacturing or qa specifications.No further information was provided.The manufacturer is closing its 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 651756-407
• MDR Report Key: 5605424
• MDR Text Key: 43542066
• Report Number: 2916596-2016-00777
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: 106015
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2013
• 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: 21 YR
• Patient Weight: 75