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

Model Number 106015

Device Problem Fracture (1260)

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

Event Date 01/16/2019

Event Type  Injury  

Manufacturer Narrative

Approximate age of device - 3 years, 6 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) 2015.It was reported that patient was seen in clinic for a follow-up appointment, noted to have a driveline twisted and tangled which was customary for this patient.It was reported that upon teaching the patient how to untangle the driveline, the vad coordinator noted a small slit in the driveline.The patient was asked to stay and wait for a silicone tape to temporarily repair the driveline.The patient stated that had an appointment in town and need to leave soon.The patient was made aware of the danger to self with their driveline condition; however, the patient made decision to leave the clinic before the repair tape could be applied.No further information was provided.

Event Description

Additional information was provided on 23jan2019 regarding patient information and the pump vad-57767 serial number.It was reported that the patient rescue tape was applied.No further information was provided.

Manufacturer Narrative

Sections d4, h4, h8: additional information.Section d6: correction.Manufacturer's investigation conclusion: analysis of the submitted photo confirmed damage to the outer silicone jacket of the patient¿s driveline.The account communicated that the patient¿s driveline was twisted and tangled which is customary for this patient.The patient was taught how to untangle the driveline and a small slit was noted in the driveline.No alarms were reported for this event.It was later reported that the patient used rescue tape / silicone tape over the cut on the driveline as instructed by another center.The other center reported no patient symptoms or alarms.The patient remains ongoing on heartmate ii lvas, serial number (b)(4) and no additional complaints have been reported at this time.The hmii lvas ifu and patient handbook explain that all hm ii lvas drivelines have the potential for wire/shield breakdown to occur dependent on length of use and movement/flexing over time.Information regarding driveline care can also be found in both of these documents.No further information was provided.The manufacturer is closing the file on this event.

• 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
• MDR Report Key: 8267952
• MDR Text Key: 133762166
• Report Number: 2916596-2019-00348
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2017
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 73