MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC; CENTRIMAG LVAD

Model Number 201-303300

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888)

Event Date 05/29/2015

Event Type  Death  

Event Description

A (b)(6) female admitted to (b)(6) on (b)(6) 2015 with cad with acute chronic systolic heart failure.Referring cardiologist dr.(b)(6).Pt with dyspnea on exertion and le edema.Pmh: chf, treated with iv lasix, dysonea, hypoxia, hypotension managed with pressors and isotropes.Pt referred to (b)(6) for mvr for severe mr.Pt underwent various procedures including ultrasound guided thoracentesis, mvr, picc lines, placement of central venous access and placement of arterial line, shiley cath for dialysis and on (b)(6) 2015, a cad was places for cardiogenic shock inserted by (b)(6), md.Medical record supports various discussions with pt's family for withdrawal of care.On (b)(6) 2015, it was reported that on repositioning of pt the pt's device became dislodged from the centrimag, resulting in bleeding.Pt coded and expired.

• Brand Name: THORATEC
• Type of Device: CENTRIMAG LVAD
• Manufacturer (Section D): THORATEC CORPORATION; pleasanton CA 94588
• MDR Report Key: 4833893
• MDR Text Key: 5945087
• Report Number: 4833893
• Device Sequence Number: 1
• Product Code: DWA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 201-303300
• Device Lot Number: L03226-0001
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/29/2015
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 71 YR