MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSISST) BYPASS

Model Number 106524US

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Arrhythmia (1721); Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 03/10/2022

Event Type  Injury  

Event Description

It was reported that the patient presented with an episode of atrial tachycardia on (b)(6) 2022 in which the patient was restarted on amiodarone.X-ray performed on (b)(6) 2022 shows sternal wire position change and appeared twisted.The patient complained of pain at sternum.A chest computed tomography (ct) was done to assess the sternum.The sternal wire pulled cut the sternum and showed dehiscence.The patient is scheduled for a rewire on (b)(6) 2022.On (b)(6) 2022, the patient underwent bronch and valsalva for lung expansion and received 2 units of fresh frozen plasma (ffp).Additional information requested but not provided.

Manufacturer Narrative

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

Manufacturer Narrative

Correction on section g2: company representative was inadvertently checked.Manufacturer's investigation conclusion: a direct correlation between the heartmate (hm) 3 left ventricular assist system (lvas) (b)(6) and the reported events could not be conclusively established through this investigation.The patient remains ongoing on heartmate (hm) 3 left ventricular assist system (lvas), serial number (b)(6).No product is available for investigation.The heartmate 3 lvas ifu, rev.C and the heartmate ii patient handbook rev.D are currently available.The heartmate 3 left ventricular assist system instructions for use lists bleeding, cardiac arrhythmia, and wound dehiscence as adverse events, as well as a potential late postimplant complication that may be associated with the use of the heartmate 3 left ventricular assist system.Section 6, ¿patient care and management¿ also provides information regarding anticoagulation, including the recommended international normalized ratio (inr) values.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 13feb2022.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSISST) 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: 14021614
• MDR Text Key: 288668190
• Report Number: 2916596-2022-01829
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/08/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8324486
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2022
• 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 Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 133 KG