MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

Model Number 106015

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stroke/CVA (1770)

Event Date 12/29/2016

Event Type  Injury  

Manufacturer Narrative

Approximate age of device ¿ 2 months 5 days.Manufacturer's investigation conclusion: the device remains implanted and the patient continues on vad support.A correlation between the device and the reported event could not be conclusively determined.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.No further information is available.The manufacturer is closing the file on this event.

Event Description

The patient was implanted with a left ventricular assistance device (lvad) on (b)(6) 2016.It was reported that the patient presented to a local hospital with left facial droop, slurred speech, and right hemiparesis on (b)(6) 2016.A cta revealed basilar artery occlusion.On (b)(6) 2017, the patient was admitted for rehabilitation of stroke.Intravenous tpa (tissue plasminogen activator) therapy was not administered due to the patient being 6 hours out from onset of symptoms.Intubation was required due to declining mental status.An emergent angiography revealed complete basilar apex occlusion with reportedly "good" filling after thrombectomy.On (b)(6) 2017, the patient was extubated with same neurologic deficits.A follow-up cta on (b)(6) 2017 revealed right internal capsule, posterior limb infarct, right anterior thalamic infarct, and severe right pca p2 segment.Tee revealed lvef 20-25%, no thrombus.Carotid dopplers showed critical left carotid artery stenosis.Of note, the patient was treated for klebsiella pneumoniae uti and hcap with vancomycin and zosyn from (b)(6) 2016 through (b)(6) 2017.Levophed was required during this time to maintain mean arterial pressure (map) to greater than 65 mmhg.After being transferred to another hospital for further stroke management, the patient continued antibiotic coverage with iv cefepime then switched to oral bactrim for 10 days for the uti.Levophed was subsequently weaned off.Neurology approved iv heparin due to subtherapeutic coumadin.Atorvastatin was started.Pt, ot, and speech therapy were started.A tte with ramp showed good pump function.An eeg was performed due to mental status changes but was negative for seizures.A repeat head ct was negative for bleeding.Once cleared by neurology, warfarin, persantine, and aspirin were started.Fees by speech therapy eventually cleared the patient for a regular texture diet with honey-thick liquids.Urology enlarged the patient¿s foley catheter to 22 f as part of their monthly catheter changes for panurethral stricture.Therapists recommended inpatient rehab.The case was reviewed and approved for admission by the physical therapy and rehabilitation physician.

• Brand Name: HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA
• Type of Device: LEFT VENTRICULAR ASSIST SYSTEM
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 8205800
• MDR Text Key: 131699919
• Report Number: 2916596-2018-05800
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2019
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 123