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

Catalog Number 500101

Device Problems Material Too Rigid or Stiff (1544); Physical Property Issue (3008)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 08/30/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The patient was implanted with the syncardia temporary total artificial heart (tah-t) on (b)(6) 2014 and was on tah-t support for 464 days at the time of the reported issue.The customer also reported that the patient's tah-t cannulae were brittle and stiff.This had been reported previously when the customer performed cannula tear repairs for the patient (reported by syncardia under mfr report #3003761017-2016-00131).The customer also reported that there was no adverse impact to the patient, and the patient was successfully transplanted on (b)(6) 2016.This alleged failure mode posed a low risk to the patient because it did not prevent the tah-t system from performing its life-sustaining functions.The tah-t cannulae will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.

Manufacturer Narrative

The tah-t cannulae were returned to syncardia for evaluation.The customer-reported cannula stiffness was confirmed through physical examination of the returned sections of cannulae.It is likely that the stiffness of the cannulae resulted from exposure to environmental factors in the patient's surroundings.This exposure could have led to loss of plasticizers from the cannula material, causing the cannula to become less flexible.The investigation could not definitely determine the source of the customer- reported stiffness.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4).Follow-up report 1.

Event Description

The patient was implanted with the syncardia temporary total artificial heart (tah-t) on (b)(6) 2014 and was on tah-t support for 464 days at the time of the reported issue.The customer also reported that the patient's tah-t cannulae were brittle and stiff.This had been reported previously when the customer performed cannula tear repairs for the patient (reported by syncardia under mfr report #3003761017-2016-00131).The customer also reported that there was no adverse impact to the patient, and the patient was successfully transplanted on (b)(6) 2016.

• 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 (Section G): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: michael garippa ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 5943112
• MDR Text Key: 54880586
• Report Number: 3003761017-2016-00317
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2016
• 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 Catalogue Number: 500101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2012
• 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: 49 YR