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

Model Number 104911JPN

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/17/2018

Event Type  malfunction  

Event Description

It was reported that during the implant surgery a hole was discovered in the white colored part of the inflow conduit and blood was jetting out.It was noted that there were no adverse patient impacts during the surgery and the hole was closed with vascular tape to stop the bleeding.

Manufacturer Narrative

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

Manufacturer Narrative

The pump was returned and evaluated under mfr # 2916596-2022-10291.Manufacturer's investigation conclusion: a specific cause for the reported blood leakage from one of the holes in the silicone sleeve of the inflow conduit could not be conclusively determined.No device-related issues were discovered through the evaluation of the returned sealed inflow conduit, and the exact leak flow path could not be identified.The silicone sleeve was returned properly secured to the graft attachments.Vascular tape had been tied over the hole in the proximal groove of the silicone sleeve.The inflow knitted graft was properly seated within the graft nuts and free of distortion.The interior of the knitted graft revealed a thin layer of coagulated, post-explant blood, but no evidence of developed or adhered thrombus formations.Following implant, the patient remained ongoing on heartmate (hm) ii left ventricular assist system (lvas), (b)(6).The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The relevant sections of the device history record for the sealed inflow conduit were reviewed and showed no deviations from manufacturing or quality assurance specifications.The sealed inflow conduit (lot number 15824552) was shipped with the implant kit for (b)(6) on 30jan2017.The heartmate ii lvas instructions for use (ifu) and the heartmate ii patient handbook are currently available.The ifu lists bleeding as an adverse event that may be associated with the use of the heartmate ii left ventricular assist system.The ifu contains information on preparing and priming the sealed inflow conduit during implant.The ifu notes that the sealed inflow conduit graft should not leak during priming.If leaking occurs from the graft, the sealed inflow conduit should be replaced.The ifu also states that hemostasis should be obtained prior to closing the chest.Furthermore, the ifu states that during the implant process, a complete backup system (implant kit and external components) must be available on-site and in close proximity for use in an emergency.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: 14435507
• MDR Text Key: 292173637
• Report Number: 2916596-2022-11091
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: 104911JPN
• Device Lot Number: 5832301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2017
• 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: 34 YR
• Patient Sex: Male
• Patient Weight: 66 KG