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

Model Number TAH-T

Device Problem Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); Death (1802)

Event Date 04/10/2014

Event Type  Death  

Event Description

Patient 10 was implanted with the syncardia temporary total artificial heart (tah-t) at (b)(6) on (b)(6) 2014, supported by a companion 2 driver.The customer reported that on (b)(6) 2014, the patient had a massive stroke.As a result, support was withdrawn and the patient expired.The customer reported that the patient had no signs of infection, was stable but always had high flows because of the patient's large size.The customer also reported that the patient exercised by walking in the park and according to the clinical team, the patient's coagulation was well controlled and his parameters were in normal range, so the reason for the patient's stroke was not clear.The customer returned the explanted tah-t and requested that syncardia perform an evaluation.At this time, there is no evidence of a device malfunction that would have caused or contributed to the patient's stroke.

Manufacturer Narrative

The explanted tah-t was returned to syncardia for evaluation.The evaluation is in process, and the results 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: 3800176
• MDR Text Key: 4525098
• Report Number: 3003761017-2014-00068
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2016
• Device Model Number: TAH-T
• Device Catalogue Number: 500101
• Device Lot Number: 086137
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/17/2014
• Date Manufacturer Received: 04/10/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2013
• 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 Outcome(s): Death
• Patient Age: 47 YR