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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TAH-T; BIVENTRICULAR REPLACEMENT DEVICE
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SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TAH-T; BIVENTRICULAR REPLACEMENT DEVICE Back to Search Results
Catalog Number 500101
Device Problems Material Rupture (1546); Device Issue (2379); Torn Material (3024)
Patient Problem Death (1802)
Event Date 10/06/2016
Event Type  Death  
Manufacturer Narrative
The 70cc tah-t was returned to syncardia for evaluation and has been sent to an approved outside laboratory for root cause analysis.The results of the investigation will be provided in a follow-up mdr.(b)(4).
 
Event Description
Patient (b)(6) was implanted with the syncardia 70cc tah-t (l/n 087165) at (b)(6) on (b)(6) 2013 and was supported for 1,067 days.The customer reported that the patient expired on (b)(6) 2016 and the tah-t was subsequently explanted.The (b)(6) pathologist was instructed by syncardia personnel on-site on the proper method to open the tah-t without causing any damage.The pathologist opened the tah-t and reported that the blood diaphragm, a component of the tah-t, appeared torn.
 
Manufacturer Narrative
The 70cc tah-t was returned to syncardia for evaluation.During explant analysis at syncardia, the technician also noted the apparent tear in the right ventricle.The tah-t l/n 087165 was sent for evaluation by a contract laboratory that had previously conducted tah-t diaphragm analyses.The results of the investigation and evaluation from the contract laboratory concluded that the root cause of the blood diaphragm failure was thinning of the blood diaphragm likely attributable to contact abrasion with the adjacent intermediate diaphragm.There was no evidence of defect in the tah-t ventricle materials.A device history record (dhr) was reviewed.The dhr file included all required documents and all were complete.All required procedures, including those pertaining to graphite between diaphragm layers to minimize abrasion, were documented as having been completed and required inspections had documented acceptable outcomes.Syncardia has initiated a corrective and preventive action (capa) to identify appropriate actions to prevent contact abrasion excess wear.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4).
 
Event Description
Patient (b)(6) was implanted with the syncardia 70cc tah-t (l/n 087165) at (b)(6) on (b)(6) 2013 and was supported for 1,067 days.The customer reported that the patient expired on (b)(6) 2016 and the tah-t was subsequently explanted.The (b)(6) pathologist was instructed by syncardia personnel on-site on the proper method to open the tah-t without causing any damage.The pathologist opened the tah-t and reported that the blood diaphragm, a component of the tah-t, appeared torn.
 
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Brand Name
SYNCARDIA 70CC TAH-T
Type of Device
BIVENTRICULAR REPLACEMENT DEVICE
Manufacturer (Section D)
SYNCARDIA SYSTEMS, LLC
1992 e. silverlake road
tucson AZ 85713
Manufacturer Contact
michael garippa
1992 e. silverlake road
tucson, AZ 85713
5205451234
MDR Report Key6069674
MDR Text Key58913905
Report Number3003761017-2016-00348
Device Sequence Number1
Product Code LOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/06/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2016
Device Catalogue Number500101
Device Lot Number087165
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/18/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received02/24/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/31/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age31 YR
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