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

Model Number 104911

Device Problem Detachment Of Device Component (1104)

Patient Problems Syncope (1610); Ventricular Tachycardia (2132)

Event Date 09/09/2012

Event Type  Injury  

Event Description

A case report titled "left ventricular assist device outflow graft disconnection" from the canadian journal of cardiology reported a pt "with symptoms of bleeding and syncopal ventricular tachycardia associated with an outflow graft bend relief disconnection, which can be diagnosed by simple roentgenography.A 50 year old man with dilated cardiomyopathy underwent an uneventful lvad implantation; however, on postoperative day 10, he experienced symptomatic episodes of ventricular tachycardia only when being positioned in a sitting or upright state.These episodes of syncopal ventricular tachycardia were refractory to medical treatment, including antiarrhythmic agents and modulation of device parameters.Consequently, the pt's transplant list status was increased.The pt received a heart, and during transplantation the lvad was sen to have a bend relief disconnection.This device graft complication could have accounted for this pt's cause of symptomatic ventricular tachycardia.A routine chest roentgenogram was able to demonstrate the complete disconnection of hm ii bend relief mechanism when compared with a normal lvad chest radiograph.

Manufacturer Narrative

No further info is available at this time.A supplemental report will be submitted when the manufacturer's investigation is completed.Reported of disconnection of the bend relief from the sealed outflow graft have been addressed through the manufacturer's corrective/preventative action system, updated device labeling, an urgent medical device correction notice (2916596-2/24/12-001-c) and a sealed outflow graft bend relief collar (sobr collar) used to secure the bend relief to the sealed outflow graft and increase the assembly's resistance to forces that would tent to dislodge the bend relief.This design modification was approved in a pma supplement and has been implemented.No further info is available.

Manufacturer Narrative

Although the report of a disconnected sealed outflow bend relief was confirmed via scans, a specific time in which it became disconnected could not be determined as the pump was not returned to the manufacturer for evaluation.It was reported that the patient was implanted after the urgent medical device correction notice that was provided to customers on (b)(6) 2012.A corrective action has since been implemented and the manufacturer's approved labeling has since been updated to reflect the enhanced instructions.A review of device history records showed no deviations from manufacturing or qa specifications.No further information is available.The manufacturer is closing its file on this event.

• Brand Name: HEARTMATE LL LVAS
• Type of Device: LEFT VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): THORATEC CORP.; pleasanton CA
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: robert fryc ; 23 fourth avenue; burlington, MA 01803 ; 7812720139
• MDR Report Key: 3865653
• MDR Text Key: 17927563
• Report Number: 2916596-2014-00816
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 04/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2014
• Device Model Number: 104911
• Device Catalogue Number: 104911
• Device Lot Number: 111700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/09/2012
• Event Location: Hospital
• Date Report to Manufacturer: 04/22/2014
• Date Manufacturer Received: 03/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2916596-2/24/12-001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 103