MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE OUTFLOW GRAFT

Catalog Number 103393

Device Problems Detachment Of Device Component (1104); Cut In Material (2454)

Patient Problems Infarction, Cerebral (1771); Neurological Deficit/Dysfunction (1982); Blood Loss (2597)

Event Date 03/09/2016

Event Type  Injury  

Manufacturer Narrative

Device unique identifier (udi) ¿ device was manufactured prior to the udi labeling implementation.Approximate age of device ¿ 4 years, 10 months.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) on (b)(6) 2011.It was reported that the patient presented to a local hospital with stroke-like symptoms.The patient was transferred to the implanting center and upon arrival, a bulge near the xiphoid process.Was observed.A chest ct scan revealed blood leakage from the lvad outflow graft.The next day, the patient was taken to the operating room for further assessment.Upon chest entry it was found that the outflow graft bend relief was disengaged and had cut into the outflow graft, causing leakage of blood into the patient's chest cavity.The outflow graft was replaced via a graft-to-graft anastomosis and a bend-relief collar was applied.On (b)(6) 2016, the patient was reported as doing okay.Neurology service had been consulted for the acute stroke but a workup was not performed as the outflow graft thrombus was the suspected source.The patient is receiving physical and occupational therapy and was transferred to a rehabilitation facility.

Manufacturer Narrative

Additional information: the report of a disengaged sealed outflow graft bend relief was confirmed based on the submitted photograph.The photograph showed the sealed outflow graft bend relief disengaged from the outflow graft attachment.Although the outflow graft was not visible, the graft attachment and attachment clip hardware were not concentric and had become angled.The reported tear and thrombus were not visible in the photograph.According to the information, after the sealed outflow graft was exchanged and the bend relief collar was installed, the patient remains ongoing on pump support and no further related issues have occurred since.The instructions for use lists stroke and device thrombus as potential adverse events that may be associated with the use of the heartmate ii left ventricular assist system.A review of the device history records showed no deviations from manufacturing or qa specifications.No further information was provided.The manufacturer is closing its file on this event.

• Brand Name: HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE OUTFLOW GRAFT
• Type of Device: LEFT VENTRICULAR ASSIST DEVICE 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 651756-407
• MDR Report Key: 5553131
• MDR Text Key: 42028651
• Report Number: 2916596-2016-00654
• 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
• Type of Report: Initial,Followup
• Report Date: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2013
• Device Catalogue Number: 103393
• Device Lot Number: 117979
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 75