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

Catalog Number 104911

Device Problem Detachment Of Device Component (1104)

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

Event Date 11/13/2014

Event Type  malfunction  

Event Description

The patient was implanted with a left ventricular assist device (lvad).It was reported that the patient¿s pump was explanted on (b)(6) 2014 due to recovery.During explant, it was noted that the outflow graft bend relief was disconnected.

Manufacturer Narrative

This medwatch report was previously submitted to fda on 12/11/2014 (3rd ack received) with mfr report # 0002916596-2014-02178.It was discovered that due to technical issues post emdr implementation, this event was submitted with a mfr report # that had already been used for a medwatch report previously submitted via mail.This resubmission of the medwatch report has a corrected (new) mfr report # in accordance with guidance received via communications with cdrh emdr (emdr@fda.Hhs.Gov).Approximate age of device: 2 years and 10 months.The device was returned to the manufacturer, and is currently being analyzed.No further information is available at this time.A supplemental report will be submitted when the device analysis is completed.Placeholder.

Manufacturer Narrative

The pump was returned to the manufacturer for evaluation.During the evaluation, a white, tissue-like lining was observed located around the opening of the inlet tube and a red, tissue-like lining was observed on the interior of the knitted graft of the inflow conduit.Both linings were adhered and although they appeared to be thicker than what is typically observed in these locations, they did not appear to be obstructing flow through the inflow conduit.In addition, a specific cause for their development could not be conclusively determined.Prior to disassembly, the proximal-side of the inlet stator and the distal-side of the outlet stator revealed no adhered depositions or thrombus formations; however, upon disassembly, the evaluation of the pump revealed that a deposition was attached to the inlet bearing cup and ball and a deposition was in the outlet stator.The deposition attached to the inlet bearing cup and ball appeared to have formed in laminated layers, which is an indication that it likely developed over an undetermined period of time while the pump was supporting the patient.The deposition in the outlet stator was loosely seated.There was no evidence of lamination or denaturing and there were no contact marks on the rotor to indicate that it was present in the pump while it was operating.The disassembled pump¿s bearings, rotor, and blood-contacting surfaces were examined under a microscope, and no abnormalities were observed.A specific cause for the disengaged sealed outflow graft bend relief and the time at which it occurred could not be determined through this evaluation.The graft material was examined and was free of any damage.The interior of the graft showed no deposition or thrombus formation to indicate a flow obstruction.The returned portion of the percutaneous lead was tested for electrical continuity and all wires were found to be electrically intact.The pump was cleaned, reassembled, and functionally tested under loaded conditions using a mock circulatory loop.The retrieved data from our testing revealed normal pump power consumption comparable to the pump power consumption recorded during the manufacturing process, and the pump operated as intended.Reports 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 tend to dislodge the bend relief.This design modification was approved in a pma supplement and has been implemented.This patient was implanted on (b)(6) 2012, prior to the urgent medical device correction notice that was issued on 02/23/2012.No further information is available.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; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: robert fryc ; 23 fourth avenue; burlington, MA 01803 ; 781272-013
• MDR Report Key: 4372541
• MDR Text Key: 5263178
• Report Number: 2916596-2014-02306
• 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: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 11/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2013
• Device Catalogue Number: 104911
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2916596-2/24/12-001-C
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 62