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

Model Number 104911

Device Problems Mechanical Problem (1384); Decreased Pump Speed (1500); Pumping Stopped (1503)

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

Event Date 06/29/2022

Event Type  malfunction  

Event Description

It was reported that the patient noticed the pump running light was only half on.The history was looked at and the patient had multiple pump stops.The driveline was a bit beat up.The log file review revealed 22pump stops and 16 low speed advisories on 25jun2022, 27jun2022, and 28jun2022.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 mobile power unit.The section of the driveline immediately coming out of exit site was twisted according to x-rays.A driveline repair was performed on (b)(6) 2022.Performed repair about 3 inches from the exit site.Post repair tethered patient on grounded pt.Cable without issue.

Manufacturer Narrative

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

Manufacturer Narrative

D9: a portion of the percutaneous lead was returned for evaluation.Incidental finding: evaluation of the submitted photo, as well as the returned portion of driveline, revealed superficial damage to the silicone jacket of the patient¿s driveline.Manufacturer's investigation conclusion: review of the patient¿s submitted log file confirmed low speed operation and pump stop events, however, evaluation of the patient¿s replaced portion of the driveline from (b)(4) did not find damage that could have contributed to the events seen within the log file.Based on past experience with the heartmate ii left ventricular assist system (lvas) and similar reported events, these events could be indicative of an issue with the driveline.The submitted log file contained data from (b)(6) 2022 to (b)(6) 2022.The log file recorded intermittent low speed operation and pump stop events on (b)(6) 2022, (b)(6) 2022, and (b)(6) 2022.The patient was operating on their mobile power unit 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.The patient underwent a driveline replacement on 30jun2022.The returned portion of driveline measured approximately 19.5 inches.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 layers were carefully removed, and microscopic examination of the underlying wires under a microscope along with high potential testing did not reveal any insulation breaches that would have contributed to an electrical short.Evaluation of the returned portion of the patient¿s driveline did not reveal any issues that could have potentially contributed to the abnormal pump operation captured in the log files.The patient reportedly was placed on an ungrounded patient cable following the distal end driveline repair.Multiple requests for additional information were issued to the customer; however, no further information was provided.The patient remains ongoing on ventricular assist device (vad) support on an ungrounded patient cable with no further issues reported at this time.The heartmate ii left ventricular assist system (lvas) instructions for use (ifu) and patient handbook provide information on caring for the driveline and identifying potential driveline issues; however, all heartmate ii lvad drivelines have the potential for wire/shield breakdown to occur dependent upon length of use and patient handling.The hmii patient handbook also contains information regarding all system alarms and the actions associated to resolve the alarms.The investigation found the incidental finding of evaluation of the submitted photo, as well as the returned portion of driveline, revealed superficial damage to the silicone jacket of the patient¿s driveline.The device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.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 7 ¿alarms and troubleshooting¿ describes all alarm conditions 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 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 (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: 15015396
• MDR Text Key: 304026879
• Report Number: 2916596-2022-12129
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011170
• UDI-Public: 00813024011170
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2021
• Device Model Number: 104911
• Device Catalogue Number: 104911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 07/14/2022
• Supplement Dates Manufacturer Received: 09/21/2022
• Supplement Dates FDA Received: 09/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2013
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 107 KG