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

Catalog Number 104911

Device Problems Detachment Of Device Component (1104); Occlusion Within Device (1423)

Patient Problem Hematoma (1884)

Event Date 03/18/2016

Event Type  Injury  

Manufacturer Narrative

The referenced driveline damage was reported under medwatch mfr report # 2916596-2016-00722.Approximate age of device ¿ 4 years, 2 months.The device was returned for analysis.The evaluation is not complete.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was implanted with a left ventricular assist device (lvad).It was reported that during a pump exchange procedure due to driveline damage, it was noted that the bend relief and outflow graft were completely detached from the pump.Upon further inspection a pseudoaneurysm was noted, occluding the outflow graft.Initially, the surgery was going to be a minimally invasive pump exchange and instead required an open procedure.A repeat sternotomy and pump exchange was performed on (b)(6) 2016.The patient is currently doing well with no neurological deficits to date.

Manufacturer Narrative

The report of a disengaged sealed outflow graft bend relief was confirmed.Review of the submitted x-ray images showed the outflow graft attachment connected to the pump outlet elbow.However, the bend relief hardware was not attached and appeared to be positioned nearly perpendicular to the graft attachment.The sealed outflow graft was returned with the bend relief detached from the graft attachment.Examination of the sealed outflow graft found a tear at the graft attachment.The graft attachment hardware adjacent to the tear showed a worn and flattened spot that appeared to correspond to wear marks and damage observed on the proximal edge of the bend relief hardware.The tear and wear marks on the graft attachment appeared consistent with rubbing against the attachment clip of the disengaged sealed outflow graft bend relief.Tissue and clotted blood on the exterior surface of the sealed outflow graft, adjacent to the tear, appeared consistent with the reported pseudoaneurysm.However, no occlusive deposition or thrombus formation was observed in the lumen of the sealed outflow graft.Reports of disconnection of the bend relief from the sealed outflow graft have been addressed through the manufacturer's corrective/preventative action system.The device labeling was updated, an urgent medical device correction notice (2916596-2/24/12-001-c) was issued on 02/23/2012, and a sealed outflow graft bend relief collar (sobr collar) was approved in a pma supplement and was implmented for use 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.Device thrombosis 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.The patient remains ongoing on lvad support with the replacement device.A review of the device history records revealed no deviations from manufacturing or quality assurance specifications.The manufacturer is closing the 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; pleasanton CA 94588
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 651756-407
• MDR Report Key: 5589836
• MDR Text Key: 43098251
• Report Number: 2916596-2016-00739
• 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: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 03/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2016
• Is this an Adverse Event Report?: Yes
• 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: 03/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 2916596-2/24/12-001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 95