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

Catalog Number 106016

Device Problems Cut In Material (2454); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 08/18/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Approximate age of device ¿ 1 year, 7 months.The event occurred at (b)(6).No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is complete.

Event Description

The patient was implanted with a left ventricular assist device (lvad).It was reported that during an outpatient clinic visit, the patient reported that there was a small cut in the silicon part of the driveline.The distributor's representative evaluated the driveline and noted some fluid underneath the silicon of the driveline.As it reportedly looked like soap, it was assumed to be residue after showering.A tape repair was performed.The following week, the patient reported a small new puncture just above the repaired point, where now blood was exiting from.All device parameters remained stable and the patient was reportedly feeling well.The cut in the driveline was covered with a sterile compress to let the blood drain out.On 08/22/2016, the distributor's presentative sealed off the puncture with silicon and closed it further with rescue tape.No further information was provided.

Manufacturer Narrative

The report of damage to the outer silicone jacket of the driveline was confirmed through an examination of the submitted photograph.The observed damage was reportedly repaired with rescue tape and silicone.X-ray images of the patient¿s driveline were submitted for review and appeared unremarkable.The patient remains ongoing on lvad support.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, EUROPE
• 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 ; 6517564071
• MDR Report Key: 5949266
• MDR Text Key: 54669807
• Report Number: 2916596-2016-01787
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: 106016
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2014
• 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 Age: 48 YR
• Patient Weight: 95