MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART

Model Number TAH-T

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/30/2013

Event Type  malfunction  

Event Description

The patient was implanted with the syncardia temporary total artificial heart (tah-t), supported by a circulatory support system (css) console, on (b)(6) 2013.She was subsequently switched from the css console to a freedom driver and was discharged to home on (b)(6) 2013.The customer reported that on (b)(6) 2013, after 259 implant days, the patient went to the hospital to report a crack in her left cannula.The cannula was repaired by removing the section of cannula with the crack and replacing it with a new section of cannula.The patient was discharged to home on (b)(6) 2013.There was no reported adverse impact on the patient as a result of the cannula crack or the subsequent repair.

Manufacturer Narrative

As of (b)(4) 2014, (b)(4) patients out of (b)(4) syncardia tah-t patients have reported cannula tears, for an occurrence rate of (b)(4).Syncardia initiated a corrective action (capa) to investigate the root cause of tah-t cannula tears.The investigation is in process.Syncardia requested that the section of damaged cannula that was removed be returned to syncardia for evaluation.The results of the investigation will be provided in a supplemental mdr.

• Brand Name: SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART
• Type of Device: ARTIFICIAL HEART
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; tucson AZ
• Manufacturer Contact: carole marcot, esq, vp ; 1992 e. silverlake rd.; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 3836388
• MDR Text Key: 4503997
• Report Number: 3003761017-2014-00006
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 01/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2013
• Device Model Number: TAH-T
• Device Catalogue Number: 500101
• Device Lot Number: 073904
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/30/2013
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 45 YR