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

Model Number 104911

Device Problems Detachment Of Device Component (1104); Power Problem (3010)

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

Event Date 07/11/2014

Event Type  malfunction  

Event Description

The pt was implanted with a left ventricular assist device (lvad).The vad coordinator reported that the silicone of the percutaneous lead (lead) was separating at a previous clamshell repair site and exposing wires.The pt has had no pump stoppages but has had many low voltage advisory alarms.Additional info provided to the mfr indicated that the pt and his wife had removed the clamshell repair on the lead, taped the lead with electrical tape, and "reinstalled" the clamshell themselves.The pt also mentioned that he would change his most depleted battery last instead of first, causing the low voltage/low battery advisories.A percutaneous lead eval was performed and revealed that the outer silicone jacket was torn near the bend relief.No broken wires were found during troubleshooting.An external percutaneous lead replacement was successfully performed by the mfr's technical services team.

Manufacturer Narrative

The pump is still in use supporting the pt; however, the replaced portion of the percutaneous lead was returned to the mfr for eval.A supplemental report will be submitted when the manufacturer's investigation is completed.

• Brand Name: HEARTMATE II LVAS
• Type of Device: LEFT VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): THORATEC CORP.; pleasanton CA
• Manufacturer (Section G): THORATEC CORP.; 6035 stoneridge dr.; pleasanton CA 94588
• Manufacturer Contact: robert fryc ; 23 fourth ave.; burlington, MA 01803 ; 7812720139
• MDR Report Key: 4174506
• MDR Text Key: 19764087
• Report Number: 2916596-2014-01336
• 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: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2014
• Device Model Number: 104911
• Device Catalogue Number: 104911
• Device Lot Number: 119687
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/16/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/11/2014
• Device Age: 15 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/11/2014
• Date Manufacturer Received: 07/11/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/18/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR