MAUDE Adverse Event Report: THORATEC CORP. HEARTMATE II LVAS

Model Number 104911

Device Problems Use of Device Problem (1670); Cut In Material (2454); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 07/21/2014

Event Type  Injury  

Event Description

The patient was implanted with a left ventricular assist device.It was reported that the patient was admitted with infection concerns but was also noted to have 2 small tears in his external driveline coating.It was reported that the small tears appear to be minor and was repaired with rescue tape.The patient's log file history showed several "low voltage" events, mainly in the evenings, and he admits to often letting his batteries run all the way down frequently, but otherwise things appear to be fine.A review of the submitted x-rays-showed some thinning of the grounding mesh near the bend relief.It was reported by the hospital staff that the patient has had a driveline infection for ages, in multiple po antibiotics for some time but most recently he was admitted for worsening of the infection and treated with iv abx.No other information was made available.

Manufacturer Narrative

No further information is available at this time.A supplemental report will be submitted upon completion of the manufacturer's investigation.

• Brand Name: HEARTMATE II LVAS
• Manufacturer (Section D): THORATEC CORP.; pleasanton CA
• Manufacturer Contact: robert fryc ; 6035 stoneridge dr.; pleasanton, CA 94588 ; 7812720139
• MDR Report Key: 4059175
• MDR Text Key: 4862765
• Report Number: 2916596-2014-01508
• 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: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2013
• Device Model Number: 104911
• Device Catalogue Number: 104911
• Device Lot Number: 109872
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/21/2014
• Event Location: Hospital
• Date Report to Manufacturer: 07/22/2014
• Date Manufacturer Received: 07/22/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/14/2011
• 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): Required Intervention
• Patient Age: 36 YR
• Patient Weight: 100