MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. CARDIOWEST TAH-T; ARTIFICIAL HEART

Device Problem Torn Material (3024)

Patient Problem Shaking/Tremors (2515)

Event Date 05/08/2016

Event Type  malfunction  

Event Description

Vad coordinator received page from patient; he paged to report that there is a "rip" in one of his drivelines and he can feel air loss at the site.States that the "rip" is on the driveline coming from his abdomen just above the zip tie.There is rescue tape present from an earlier "repair/reinforcement." no alarms at this time.Fill volume 55, br 137 co 6.7.Patient was advised to come into the cardiovascular center (cvc) asap.Patient states it would take him about an hour to get there.Vad surgeon was notified immediately.He advised rescue tape to area if appropriate and to contact syncardia rep.Syncardia rep suggested rescue tape to area if small (1/16th of an inch); if rip is bigger, may need to power up the back up freedom driver to use for change over.Rep has sent videos to perfusion re: this type of thing.Contacted perfusionist on call.Perfusionist met the patient at the cvc for further evaluation; dl site was precarious at best and patient was feeling shaky with fill volumes down to 40.Icu bed available.Patient admitted to cvc icu for further evaluation and treatment.Received page stating patient will be staying in house until further notice awaiting heart transplant, per perfusionist.The patient received a heart transplant the following day.

• Brand Name: CARDIOWEST TAH-T
• Type of Device: ARTIFICIAL HEART
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 5846257
• MDR Text Key: 51163928
• Report Number: 5846257
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/20/2016,07/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2016
• 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?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/20/2016
• Event Location: Hospital
• Date Report to Manufacturer: 07/20/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25 YR