MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II SEALED OUTFLOW GRAFT; LVAD SEALED OUTFLOW GRAFT

Catalog Number 103393

Device Problems Detachment Of Device Component (1104); Kinked (1339)

Patient Problems Stroke/CVA (1770); Neurological Deficit/Dysfunction (1982)

Event Date 06/29/2015

Event Type  Injury  

Event Description

The patient was implanted with a left ventricular assist device on (b)(6) 2012.It was reported that the patient experienced low flow alarms over a 13 day period.The average power ranged from 3.9 watts to 6.3 watts with the average flow ranging from 2.0 lpm to 6.7 lpm.The patient was asymptomatic at the time of the event.On (b)(6) 2015, an x-ray and echocardiogram were performed.The surgeon suspected a kink in the outflow graft, however, it was reported that thrombus could not be ruled out.The patient was returned to the operating room (or) for surgery.During surgery, it was observed that the bend relief had disconnected from the outflow graft, creating a kink.The surgeon re-connected the outflow graft bend relief and placed an outflow collar to secure the connection.It was noted that the surgeon had not used the sealed outflow graft bend relief collar in the original implant.No further low flow alarms occurred.On (b)(6) 2015 the patient was extubated and showed decreased left side movement.A ct revealed bilateral attenuation.The attending neurologist confirmed bilateral small strokes and suspected a hypoxic/hypotensive insult to explain the patient¿s symptoms.The patient was reported to be ¿doing okay¿ in the intensive care unit as of (b)(6) 2015.On (b)(6) 2015, it was reported that the patient was improving and was transferred to rehabilitation.

Manufacturer Narrative

Approximate age of device - 3 years 1 month.A full evaluation of the device could not be conducted as the device remains in use and the patient remains ongoing on lvad support.The report of a disengaged sealed outflow graft bend relief could not be confirmed because no images of the reported disconnect were submitted and no product is available to be returned.Stroke is listed in the instructions for use as a potential adverse event that may be associated with the use of the heartmate ii left ventricular assist system.A review of the device history records revealed the device met applicable specifications.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.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II SEALED OUTFLOW GRAFT
• Type of Device: LVAD SEALED OUTFLOW GRAFT
• 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: 4962694
• MDR Text Key: 19437190
• Report Number: 2916596-2015-01393
• 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,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2014
• Device Catalogue Number: 103393
• Device Lot Number: 127975
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 72