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

Model Number 104911

Device Problems Mechanical Problem (1384); Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 04/14/2021

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 patient had continuing tears on external percutaneous lead and rescue tap was applied.Rescue tape was re-applied.Log files contained a few pi (pulsatility index) events as well as routine power source changes the pump/flow/pi appeared to be trending fairly neutral.No other notable alarms or events were recorded.The damage to the outer jacket did not appear to affect pump operation at the time.

Manufacturer Narrative

Section b5: previous driveline damage and rescue taping is reported under mfr # 2916596-2019-05059.Manufacturer's investigation conclusion: the reported superficial jacket damage was confirmed through evaluation of submitted pictures of the driveline.The submitted log file contained data from (b)(6) 2021.The pump operated above the low speed limit for the duration of the log file.The log file captured pulsatility index (pi) events and routine power source exchanges.There were no notable events in the file.The log file appeared to show the pump operating as intended.The submitted photos revealed clear and black tape applied approximately 2 inches from the driveline exit site to the clamshell.In the submitted photos, the clear rescue tape was removed and revealed the outer jacket layer had tears.New black rescue tape was applied along the driveline.The patient is ongoing on heartmate ii left ventricular assist system, serial number (b)(6).No further related events have been 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 heartmate ii left ventricular assist system (lvas) instructions for use (ifu), rev.C is currently available.Additionally, section 1 "introduction" of the ifu provides an explanation of all pump parameters, including pump flow.Section 8, ¿equipment storage and care,¿ provides information on driveline care and cleaning under ¿care of the driveline.¿ the user should check the driveline daily for signs of damage (cuts, holes, tears) and call their hospital contact right away if the driveline is damaged (or might be damage).Heartmate ii patient handbook, rev.C is currently available.The patient handbook explains that all heartmate ii lvad drivelines have the potential for wire/shield breakdown to occur dependent upon length of use and movement/flexing over time.Section 6 entitled ¿caring for the equipment¿ outlines proper driveline maintenance for the patient under ¿driveline care.¿ if driveline damage is suspected, the user is instructed to call their hospital contact immediately.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: 11827914
• MDR Text Key: 252942916
• Report Number: 2916596-2021-02245
• 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,Followup
• Report Date: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2013
• Device Model Number: 104911
• Device Catalogue Number: 104911
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 68