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

Model Number 104911JPN

Device Problem No Apparent Adverse Event (3189)

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

Event Date 04/02/2022

Event Type  malfunction  

Event Description

It was reported that the patient underwent a routine heart transplant surgery and had the pump explanted on (b)(6) 2022.No device issue were reported.Evaluation of the returned pump found tissue growth at the proximal edge of the inlet extension.

Manufacturer Narrative

This event occurred at (b)(6) hospital in (b)(6) japan.Manufacturer's investigation conclusion: heartmate (hm) ii left ventricular assist system (lvas), serial number (b)(4) was returned assembled with the driveline (dl) severed approximately 2.25¿¿ from the pump housing.The distal portion of the dl was returned in one segment measuring approximately 37.75¿¿.The sealed inflow conduit (inlet tube, flex section, and inlet elbow) was returned attached to the pump¿s inlet port.The outlet elbow was returned attached to the pump¿s outlet port.The sealed outflow conduit (sealed outflow graft, sealed outflow graft bend relief, and outlet elbow) was returned attached to the pump¿s outlet port.The sealed outflow graft had been severed approximately 3.5¿ from its hardware.The sealed outflow graft bend relief had been severed approximately 3¿¿ from its hardware.The remaining portions of the sealed outflow graft and sealed outflow graft bend relief material were not returned.The bend relief collar was returned secured over the bend relief hardware.Upon disassembly of (b)(4), visual inspection of the blood contacting surfaces within the pump revealed no evidence of developed or adhered depositions or thrombus formations that would have contributed to a functional issue.The pump was cleaned, and the bearings, rotor and blood contacting surfaces were examined under a microscope; no anomalies related to wear or damage were observed.Electrical continuity testing of the returned portions of the driveline did not reveal any discontinuities or shorts.The pump was reassembled and functionally tested under normal operating conditions using a test distal driveline segment and a mock circulatory loop.The data retrieved from that testing revealed normal pump power consumption and pressure values that met manufacturing specification and the device functioned as intended.During the investigation there was an incidental finding of tissue growth at the proximal edge of the inlet extension.The relevant sections of the device history records for (b)(4) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate ii lvas instructions for use (ifu) and the heartmate ii patient handbook are currently available.The ifu lists adverse events that may be associated with the use of heartmate ii left ventricular assist system, including device thrombosis.This ifu also contains information regarding the recommended anticoagulation therapy and international normalized ratio (inr) range.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, JP
• 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: 15107599
• MDR Text Key: 304602355
• Report Number: 2916596-2022-12530
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2019
• Device Model Number: 104911JPN
• Device Lot Number: IFS103828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2016
• 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: 60 YR
• Patient Sex: Male