MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAD; VENTRICULAR (ASSISST) BYPASS

Device Problems Fracture (1260); Pumping Stopped (1503)

Patient Problem Pain (1994)

Event Date 11/12/2018

Event Type  Injury  

Event Description

Pt is an elderly male with heartmate 2 previously placed 4 years ago.The patient has developed chronic drainage from the driveline and fracture of the internal driveline evidenced by multiple pump stoppages last year.The patient was transferred as an emergency air transport direct to intensive care unit.He was found to have multiple pump stoppages which indicated driveline fracture.He was hemodynamically stable and still conscious.He was taken to the operating room for femoral-femoral bypass and subcostal replacement of heartmate 2 left ventricular assist device with the pump still functioning.The patient tolerated the procedure well and was taken to the cardiac intensive care unit post-procedure on moderate inotropic and vasopressor support.The patient remained intubated overnight to ensure hemodynamic stability.Remaining inotropic and vasopressor support was able to be weaned and discontinued on post-operative day #1.The patient was extubated on post-operative day #1.The swan-ganz catheter, central line, foley catheter, and the arterial line were able to be discontinued on post-operative day #2.The patient was transferred out of the cardiac intensive care unit to the cardiac telemetry floor on post-operative day #2.Once on the telemetry floor the patient progressed very well with mobilization and pain control.Remaining chest drains were discontinued on post-operative day # 4 and got discharged on post op day #9.

• Brand Name: HEARTMATE II LVAD
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge dr; pleasanton CA 94588
• MDR Report Key: 8539361
• MDR Text Key: 142754660
• Report Number: 8539361
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/19/2019

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: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/19/2019
• Event Location: Home
• Date Report to Manufacturer: 04/23/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 24090 DA
• Patient Weight: 103