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

Catalog Number 104911

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 11/24/2015

Event Type  malfunction  

Manufacturer Narrative

The previous percutaneous lead replacement was reported under medwatch mfr.Report # 2916596-2014-00810.Device unique identifier (udi) - device was manufactured prior to udi labeling implementation.Approximate age of device: 3 years and 3 months.The pump remains in use supporting the patient.Approximately 18 inches of the external portion/distal end of the percutaneous lead was returned for evaluation.The reported superficial damage to the percutaneous lead was confirmed based on the submitted photo and the evaluation of the returned percutaneous lead.The photo revealed the reported separation of the proximal-end of the repaired percutaneous lead.Continuity testing of the returned portion of the percutaneous lead found open brown and green wires.Tape had been applied to the proximal end of the previous repair, and removal of the tape revealed the reported separation.The repaired area was dissected, and examination of the underlying wires revealed that the brown and green wires had come out of their crimps and shrink tubing; however, a specific time and a cause for the detachment could not be conclusively determined through the evaluation.The bionate and shielding were removed to examine the underlying wires.No evidence of wear or damage to the wires was found.The 18¿ portion of lead was submerged in a saline bath for hipot 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 hipot testing.A review of the device history records revealed 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's previous percutaneous lead repair had come apart and the wires were exposed.The health professional applied rescue tape to the area.No alarms were reported, and the patient remained asymptomatic during the event.On (b)(6) 2015, the manufacturer's technical services representative evaluated the percutaneous lead, and during the electrical continuity test, the brown and green wires showed no continuity.The patient did not report any damage or trauma to the percutaneous lead that could have caused the two broken wires.The repair was completed above the prior repair with no issues.The patient was then connected to a grounded patient cable after the repair and no alarms were elicited.

• 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: 5317288
• MDR Text Key: 34076406
• Report Number: 2916596-2015-02412
• 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: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2014
• Device Catalogue Number: 104911
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2015
• Initial Date FDA Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2012
• 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: 33 YR
• Patient Weight: 100