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

Model Number 104911

Device Problem Mechanical Problem (1384)

Patient Problems Heart Failure (2206); Discomfort (2330); Heart Failure/Congestive Heart Failure (4446)

Event Date 12/21/2020

Event Type  Injury  

Manufacturer Narrative

The patient had previously experienced driveline fault alarms as reported in mfr# 2916596-2020-00148.The results/method/conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that the patient was admitted to the emergency department for a "vacuum feeling" in their chest.The log files recorded driveline fault alarms.No correlation between patient sensation and pump parameters could be determined.The patient had diuresis and had a short hospital course for heart failure management.There were no other abnormal alarms or events recorded.The patient was kept on an ungrounded cable and discharged home.

Manufacturer Narrative

Manufacturer investigation conclusion: incidental findings: review of the submitted log file demonstrated progression of the driveline fault from an issue with phase 1 of the driveline to an issue with both phases 1 and 2 of the driveline.Pump function did not appear to have been interrupted.Review of the submitted log file confirmed silenced driveline fault alarms; however, it was reported that the patient had a known driveline fault (previously reported under mfr # 2916596-2020-00148).A specific cause for the report of a ¿vacuum feeling in chest¿ could not be conclusively determined through this evaluation, and a direct correlation with heartmate ii left ventricular assist system (lvas), serial number (b)(6), could not be conclusively established.A review of the submitted log file from 13dec2020 through 21dec2020 found that the pump maintained a stable speed above the low speed limit without issue.A silenced driveline fault alarm with an associated yellow wrench advisory alarm was captured through most of the log file.The system otherwise appeared to be operating as intended, and there were no other notable alarms active in the log file.The patient remains ongoing on (b)(6) with no further related events reported at this time.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit shipped on 17may2013.The heartmate ii left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 1 ¿introduction¿ of this document lists bleeding (perioperative or late) as an adverse event that may be associated with the use of heartmate ii lvas.Section 6 ¿patient care and management¿ discusses damage due to wear and fatigue of the driveline.This section also contains information on ¿caring for the driveline¿ (under ¿ongoing system assessment and care¿) and provides possible indications of driveline damage as well as how to respond to such events.Section 7 "alarms and troubleshooting" outlines all system controller alarms as well as how to respond to each alarm condition.Section 8 ¿equipment storage and care¿ also contains information on ¿care of the driveline,¿ and provides possible indications of driveline damage.The heartmate ii lvas patient handbook is also currently available.The patient handbook instructs to ¿call your hospital contact if you think that, for any reason, any portion of your equipment is not functioning as usual, is broken, or you are uncomfortable with the operation of the equipment.¿ the patient handbook also cautions the user to call their hospital contact right away if they notice a change in how their pump sounds, feels, or works.Section 4 ¿living with the heartmate ii¿ contains information on caring for the driveline.Section 5 "alarms and troubleshooting" outlines all system controller alarms as well as how to respond to each alarm condition.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 (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11175634
• MDR Text Key: 227927391
• Report Number: 2916596-2020-06476
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011170
• UDI-Public: 00813024011170
• Combination Product (y/n): N
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2015
• Device Model Number: 104911
• Device Catalogue Number: 104911
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Weight: 66