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

Model Number 104911

Device Problems Pumping Stopped (1503); Material Separation (1562); Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2020

Event Type  malfunction  

Manufacturer Narrative

The results/method/conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that the patient had a possible phase to phase and had no driveline repair in the past.Log file reviewed, which captured low flow events on (b)(6) 2020 and (b)(6) 2020.There did not appear to be any type of equipment issues causing these events.The low flow events seemed to be a patient hemodynamically related issue and not a device related issue.The log file also captured pump stops on (b)(6) 2020 and (b)(6) 2020.This type of behavior has been linked to potential issues with the percutaneous lead.These issues appeared to be occurring on batteries.The driveline external x-ray showed a few areas of minor shield separation.The internal images showed a couple u-shaped bends in the driveline behind the pump.These bends may have been placing stress on the driveline.On (b)(6) 2020 performed a percutaneous lead replacement approximately 3 inches from the exit site.There were no issues noted after the patient was back on ungrounded cable.After the driveline repair there were no alarms on interrogation and the driveline investigation did not show any area of cause of alarms.Log file reviewed and there were no further issues seen since the repair within the log file.It was not confirmed if the percutaneous lead repair resolved the issues so the patient was advanced to a pump exchange.Manufacturer report number of new pump: 2916596-2021-00117.

Manufacturer Narrative

Manufacturer's investigation conclusion: review of the patient¿s submitted log files confirmed low speed operation and a pump stoppage; however, evaluation of the replaced portion of the driveline from (b)(6) did not find damage that could have contributed to the events seen within the log file.Additionally, superficial damage to the outer jacket was observed during evaluation of the returned portion of driveline.Finally, evaluation of the submitted log files confirmed low flow events; however, a direct cause for the reported events could not be conclusively determined through this evaluation.The submitted log files contained overlapping data from (b)(6) 2020 and from (b)(6) 2020.The log files recorded pump stoppages and/or low speed operation events on (b)(6) 2020.The patient was operating on 14v external batteries and the power module during all abnormal pump operation.Based on previous complaint experience, the type of behavior captured within the submitted log files could be indicative of a potential driveline issue.Electrical continuity testing of the replaced portion of the driveline in its returned condition revealed no discontinuities or shorts, even with manipulation of the driveline segment.The driveline was covered in rescue tape from approximately 2 inches from the controller connector through the remaining portion of the driveline.The layers were carefully removed, and the underlying wires appeared overall unremarkable with no evidence of kinking, twisting, or severe insulation abrasion.Microscopic inspection of the wires revealed no areas of compromised insulation along the length of the driveline segment.The returned portion of the driveline was then suspended in a saline bath for hipot testing to check for current leakage through the wire insulation, and no areas of compromised wire insulation were identified.Evaluation of the returned portion of the patient¿s driveline did not reveal any issues that could have potentially contributed to the reported events captured in the log files.Review of the device history records showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped to the customer on 09dec2011.The heartmate ii lvas ifu is currently available.The section entitled ¿pump performance monitoring¿ under patient care and management covers wear and tear to the driveline.The ifu warns that at least one power cable must be connected to a power source at all times.Section 1 "introduction" of the ifu provides an explanation of all pump parameters, including pump flow.Section 4 provides more information regarding all pump parameters and also describes situations which may result in a low flow hazard alarm.Section 6 "patient care and management" explains that pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling, explains that pump flow is estimated from pump power, and addresses assessing pump flow.Section 6 (under "anticoagulation") outlines the suggested anticoagulation regimen (including inr range) for patients using the heartmate ii lvas.Section 7 ¿alarms and troubleshooting¿ describes all alarm conditions including the low flow hazard as well as the appropriate actions associated with them.Patient handbook is also available.This handbook contains a section on "caring for the driveline." however, all heartmate ii lvad drivelines have the potential for wire/shield breakdown to occur dependent upon length of use and patient handling.The ¿alarms and troubleshooting¿ section outlines all system controller alarms, including driveline fault alarms, as well as how to respond to such events.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: 11175535
• MDR Text Key: 227564684
• Report Number: 2916596-2020-06507
• 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: 04/26/2021

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2013
• Device Model Number: 104911
• Device Catalogue Number: 104911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEARTMATE II LVAS IMPLANT KIT
• Patient Age: 67 YR
• Patient Weight: 53