MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA 70CC TAH-T; BIVENTRICULAR REPLACEMENT DEVICE

Catalog Number 500101

Device Problems Material Rupture (1546); Device Issue (2379); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems Death (1802); Tissue Damage (2104)

Event Date 03/15/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

Tah-t l/n 072084 was returned to syncardia after explant from a patient who expired after 4 1/2 years of tah-t support.The details of the patient's death are unknown.During routine explant analysis at syncardia, the technician noted that the blood diaphragm of the right ventricle (l/n 071702r0809) appeared to be torn.Tah-t l/n 072084 had been handled abnormally following explant.The customer reported that, rather than being packaged in an approved syncardia explant retrieval kit and shipped promptly to syncardia, tah-t l/n 072084 was sent to another institution and was apparently subjected to rigorous chemical treatment and handling under undetermined conditions.Tah-t l/n 072084 will undergo further evaluation and the results of the evaluation will be provided in a follow-up mdr.

Manufacturer Narrative

Operator of device changed to health professional after the syncardia technician noted the apparent tear in the right ventricle, the tah-t l/n 072084 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 either the tah-t ventricle materials or in ventricle construction.Syncardia has completed its evaluation of this complaint and is closing this file.Ce (b)(4) follow-up report 1.

Event Description

Tah-t l/n 072084 was returned to syncardia after explant from a patient who expired after 4½ years of tah-t support.The details of the patient's death are unknown.Tah-t l/n 072084 had been handled abnormally following explant.The customer reported that, rather than being packaged in an approved syncardia explant retrieval kit and shipped promptly to syncardia, tah-t l/n 072084 was sent to another institution and was apparently subjected to rigorous chemical treatment and handling under undetermined conditions.It was only after such improper handling that syncardia received and was able to analyze tah-t l/n 072084.During the analysis at syncardia, the technician noted that the blood diaphragm of the right ventricle (l/n 071702r0809) appeared to be torn.

• 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: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 5579464
• MDR Text Key: 42814486
• Report Number: 3003761017-2016-00155
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2012
• Device Catalogue Number: 500101
• Device Lot Number: 072084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2010
• 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: 43 YR