MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

Model Number 103695

Device Problems Loose or Intermittent Connection (1371); Connection Problem (2900)

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

Event Date 07/27/2017

Event Type  malfunction  

Manufacturer Narrative

The initial submission of this event was reported by the manufacturer under mfr report #2916596-2017-01854.This report is being submitted as additional information unique identifier (udi) ¿ device was manufactured prior to the udi labeling implementation.Approximate age of device ¿ 7 years and 3 months.Manufacturer's investigation conclusion: a specific cause for the reported event could not be conclusively determined as no product was available for evaluation and no photographs of the clamshell assembly were provided.The center reported that difficulty was experienced connecting the percutaneous lead to an ep controller due to interference with the legacy clamshell which was placed in 2010.Technical services inspected the clamshell and found that it was not clamped together properly.The patient and center declined technical services¿ offer to resolve the issue via a distal end percutaneous lead replacement.The patient remains on vad support with no further issues reported.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) on (b)(6) 2010.It was reported that a clamshell repair was performed on (b)(6) 2010 due to the silastic coming apart from the metal connector at the controller end bend relief of the driveline.It was reported that when trying to insert the percutaneous lead into the system controller, there was much resistance and it seemed that the clamshell was in the way.There was no adverse patient impact due to the event, but the customer was concerned that this posed a safety issue for the patient if the need arose to exchange the system controller.On 01aug2017, the manufacturer's clinical consultant and technical representative were onsite to visually inspect the prior clamshell repair.It was reported that the clamshell clamps appeared to not be compressed together properly, which is what made the connection difficult.The clinicians decided to keep the current configuration, and would contact the manufacturer if they decided to move forward with a distal end percutaneous lead (driveline) replacement.

• Brand Name: HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA
• Type of Device: LEFT VENTRICULAR ASSIST SYSTEM
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 7741436
• MDR Text Key: 115769072
• Report Number: 2916596-2018-03016
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 103695
• Device Catalogue Number: 103695
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2018
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 64 YR
• Patient Weight: 93