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

Device Problems Obstruction of Flow (2423); Material Twisted/Bent (2981); Appropriate Term/Code Not Available (3191)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 08/19/2021

Event Type  Injury  

Event Description

Patient with implanted heartmate ii left ventricular assist device (lvad) with prior history of splice repair of driveline was admitted due to almost continual "low flow" alarms and was admitted to the intensive care unit.The patient was taken to the or where the outflow graft ring was opened, kink was released, and liquified thrombus was drained.The outflow graft was ligated closed, the lvad was decommissioned, and an impella 5.5 was implanted.The patient was upgraded for heart transplant and was successfully transplanted on 2021.

• Brand Name: HEARTMATE II
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 12532103
• MDR Text Key: 273325197
• Report Number: 12532103
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/09/2021
• Device Age: 4 YR
• Event Location: Home
• Date Report to Manufacturer: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 23725 DA
• Patient Weight: 104