MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, JP; VENTRICULAR (ASSISST) BYPASS

Model Number 104911JPN

Device Problems Fracture (1260); Decreased Pump Speed (1500); Pumping Stopped (1503); Electrical Shorting (2926)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/06/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient had a recorded pump off and low speed operations.Noted multiple pump stops and low speed operations which drop below the patients low speed limit of 8000 rpm.This type of behavior has been linked to potential issues with the percutaneous lead.These issues only appear to be occurring while the vad is connected to the power module.No further or additional information was provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: the evaluation of the returned portion of the driveline confirmed wire damage that would have contributed to the reported pump stop events that were captured in the submitted log file.The pump was returned assembled with the driveline (dl) cut approximately 1.25¿ from the pump housing and the distal portion of the dl was returned.The sealed inflow conduit (inlet tube, flex section, and inlet elbow) was returned detached from the pump¿s inlet port.The sealed outflow graft and outflow graft bend relief were not returned.The outflow elbow was returned attached to the pump¿s outlet port.Visual examination of the pump¿s blood-contacting surfaces upon disassembly of (b)(6) revealed no evidence of depositions or thrombus formations.Electrical continuity testing did not reveal any discontinuities.The silicone jacket and clear bionate appeared unremarkable.Visual inspection of the returned portions of the driveline revealed minor breakdown of the metal braided shield throughout the length of the driveline.Visual examination of the underlying wires revealed breaches in the insulation of orange and yellow wires 2.5¿ from the pump housing, exposing the inner conductors.The observed wire damage appeared consistent with fatigue failure due to repetitive flexing and abrasion against the metal braided shield.Both segments of the driveline were then submerged in a saline solution for hi-pot testing to further verify the integrity of each wire's insulation.The test did not reveal any additional breaches.If the exposed conductors of the compromised wires contacted the braided shield while the system was connected to a tethered power source (such as the power module) using a grounded patient cable, the resulting electrical short to ground would have caused the reported pump stoppages as captured in the submitted log file.The system also had the potential for an electrical short to occur on battery power and cause an interruption in pump function if the exposed conductors of both compromised wires made simultaneous contact with the braided shield.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient underwent a pump exchange from heartmate2 to heartmate3 on (b)(6) 2019 following a suspected driveline fracture and short-to-shield.No further or additional information was provided.

• Brand Name: HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, JP
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 9233788
• MDR Text Key: 163636247
• Report Number: 2916596-2019-04820
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• 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: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: 104911JPN
• Device Catalogue Number: 104911JPN
• Device Lot Number: IFS103828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 51