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

Model Number 107801

Device Problems Malposition of Device (2616); Infusion or Flow Problem (2964); Material Twisted/Bent (2981)

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

Event Date 06/01/2020

Event Type  malfunction  

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 chronic episodes of low flow alarms.Ct chest angiogram and 3d reconstruction in june 2020 showed mild folding in the distal aspect of the outflow graft without obstruction.

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of a kinked outflow graft could not be confirmed as no computed tomography (ct) imaging was provided for review, and no product was returned for evaluation.The reported low flow alarms could not be confirmed as no log files were submitted for review.It was reported that the patient had ct chest angio + 3d reconstruction june 2020 showing mild folding in the distal aspect of the outflow graft without obstruction.The account reported low flow alarms since then.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.The patient remains ongoing on heartmate ii left ventricular assist system (lvas), (b)(6).No product is available for investigation.The relevant sections of the device history records for (b)(6) was reviewed and showed no deviations from manufacturing or quality assurance specifications.The lvas kit shipped on 17sep2018.Heartmate ii lvas instructions for use (ifu), section 5 entitled ¿surgical procedures¿ contains information regarding the preparation and attachment of the sealed outflow graft.This section instructs the user to verify that the graft is not twisted or kinked by checking the position of the black line on the graft above and below the bend relief and ensuring that the line is straight.This section warns that failure to connect the bend relief so that it is fully and evenly connected can allow kinking and abrasion of the graft, which may to serious adverse events such as low left ventricular assist device flow and/or bleeding.Section 4 entitled ¿system monitor¿ explains that pump flow is estimated based on pump power.Section 7 entitled ¿alarms and troubleshooting¿ outlines all system controller alarms, including the low flow hazard alarm, and provides information regarding how to respond to and troubleshoot the alarms.Section 6 entitled ¿patient care and management¿ provides information regarding anticoagulation therapy and the recommended inr range.Heartmate ii lvas patient handbook,section 5 entitled ¿alarms and troubleshooting¿ outlines all system controller alarms, including the low flow hazard alarm, and provides information regarding how to respond to and troubleshoot the alarms.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11246937
• MDR Text Key: 234486078
• Report Number: 2916596-2021-00486
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011996
• UDI-Public: 00813024011996
• Combination Product (y/n): N
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2021
• Device Model Number: 107801
• Device Catalogue Number: 107801
• Device Lot Number: 6588015
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 93