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

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 12/17/2019

Event Type  malfunction  

Event Description

Patient with implanted heartmate ii left ventricular assist device (lvad) was admitted due to the second driveline fracture of 2nd heartmate ii lvad.Patient presented with lvad alarms.Waveforms were evaluated by abbott corp; short to shield occurring on grounded mobile power unit (mpu).X-rays did not reveal noticeable driveline fracture.Blind repair was not pursued at this time.Patient opted to pursue palliative management due to burden of other comorbidities including severe urinary retention/ bladder spasms/ failure to thrive with weight loss.Patient discharged home with battery power and ungrounded cable.

• Brand Name: HEARTMATE II
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 12518523
• MDR Text Key: 272971041
• Report Number: 12518523
• 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: 09/23/2021
• Is this an Adverse Event Report?: No
• 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: 3 YR
• Event Location: Home
• Date Report to Manufacturer: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25550 DA
• Patient Weight: 67