MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS); VENTRICULAR (ASSIST) BYPASS

Model Number 106015

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/11/2022

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Event Description

It was reported that there was a concern that there could be an issue with the driveline as the patient had rescue tape and a few breaks in the line.The log files did not contain any evidence of a driveline issue.

Event Description

It was reported that new black rescue tape was placed to the area of concern on the driveline and discussed with the patient about the potential for fractured wire over time including pump stops, neither of which the patient had at the time of the event.

Manufacturer Narrative

The patient had prior damage to driveline as reported under mfr #2916596-2021-05969.Manufacturer's investigation conclusion: the report of superficial damage to the silicone jacket of the patient¿s driveline could not be confirmed through this evaluation as no images were submitted for review and the patient remains ongoing on ventricular assist device (vad) support.The submitted log file contained data from 04jun2022 to 11jul2022.The pump operated above the low speed limit for the duration of the log file.There were no atypical pump related alarms and the log file appeared to show the system operating as intended.The patient remains ongoing on ventricular assist device (vad) support with no further related issues reported at this time.Review of the device history records showed no deviations from manufacturing or qa (quality assurance) specifications.The heartmate ii lvas instructions for use (ifu) is currently available.The section entitled ¿pump performance monitoring¿ under patient care and management covers wear and tear to the driveline.Heartmate ii lvas patient handbook is currently available.Section 4 of this handbook contains information on ¿caring for the driveline.¿ however, all hmii lvad drivelines have the potential for wire/shield breakdown to occur dependent upon length of use and movement/flexing over time.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 15123314
• MDR Text Key: 304001244
• Report Number: 2916596-2022-12464
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 813024011224
• 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,Company Representative
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2019
• Device Model Number: 106015
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2016
• 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 Age: 64 YR
• Patient Sex: Male
• Patient Weight: 112 KG