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

Model Number TAH-T

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2014

Event Type  malfunction  

Event Description

Pt 001 was implanted with the syncardia temporary total artificial heart (tah-t) at (b)(6), on (b)(6) 2012 and supported by a syncardia companion 2 driver.The pt was subsequently switched to a portable freedom driver.On (b)(6) 2014, ece urpermez from syncardia's distributor in (b)(4) reported that after 576 implant days, the pt's left cannula developed a small tear at the end near the cpc connector (the cpc connector connects the cannula to the freedom driver driveline).The customer also reported that the cannula tear occurred when the pt rolled on his cannulae while he was sleeping.The customer also reported that the tear was repaired by (b)(6) by cutting off the end of the cannula where the tear was located.The cannula was then reinserted into the cpc connector and wrapped with tape.The customer reported that there was no adverse impact on the pt as a result of the cannula tear or the subsequent repair.

Manufacturer Narrative

Syncardia has initiate a capa (corrective or preventive action) to address the cannula tear issue.The capa will document the investigation including, but not limited to, potential root cause and corrective actions associated with all cannula tear events.Syncardia has requested that the tah-t and cannulae be returned to syncardia after the pt is transplanted.The results of the evaluation 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: 3966199
• MDR Text Key: 15821215
• Report Number: 3003761017-2014-00081
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 06/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2015
• Device Model Number: TAH-T
• Device Catalogue Number: 500101
• Device Lot Number: 080833
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/30/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 19 YR