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

Catalog Number 500101

Device Problems Air Leak (1008); Material Discolored (1170); Device Dislodged or Dislocated (2923); Physical Property Issue (3008)

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

Event Date 02/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The reported issue involves the following syncardia temporary total artificial heart (tah-t) system components: tah-t cannulae - s/n (b)(4)-ct (mfr report #3003761017- 2016-00068) and tah-t cpc connector - s/n (b)(4)-ct (mfr report #3003761017-2015-00070).The customer reported that the tah-t cannulae are discolored and rigid.The customer also reported that the hospital staff member noticed that the spring on the tah-t cpc connector was dislodged and there was an air leak.The tah-t cpc connector is a component that provides the interface between the drivelines and the tah-t cannula.The customer also reported that the physician was able to push the spring back on the tah-t cpc connector, however the air leak did not resolve.The customer also reported that the tah-t cpc connector was successfully repaired by the physician.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the patient because the discolored and rigid cannulae and cpc connector air leak did not prevent the tah-t and freedom driver from performing their life-sustaining functions.The removed tah-t cannula piece and tah-t cpc connector will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.

Manufacturer Narrative

This report was corrected to syncardia 70cc temporary total artificial heart (tah-t).(b)(4).

Event Description

The reported issue involves the following syncardia temporary total artificial heart (tah-t) system components: tah-t cannulae - s/n (b)(4) (mfr report #3003761017- 2016-00068) and tah-t cpc connector - s/n (b)(4) (mfr report #3003761017-2015-00070).The customer reported that the tah-t cannulae were discolored and rigid.The customer also reported that there was no adverse patient impact.The customer also reported that the patient would remain in the hospital until he received a heart transplant.The patient was successfully transplanted on (b)(6) 2016.A section of the patient's discolored cannula was returned to syncardia for evaluation.Syncardia conducted a review of the tah-t device history record (dhr) and sterilization work order and confirmed that all manufacturing was performed to specifications, and the tah-t met all specified requirements prior to shipment.During visual inspection, it was noted that the cannula section was discolored and very stiff, confirming the reported issue.When force was applied to the cannula section, the material did not flex in a way that would be expected.The investigation concluded that it is likely that the discoloration and stiffness of the cannula 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 definitively determine the source of the reported discoloration and stiffness.At the time of the reported issue, 1,572 tah-t devices had been implanted, and there have been a total of four tah-t devices with reported discolored and stiff cannulae, affecting three patients (one patient was supported by two different tah-t devices, each of which developed cannulae discoloration).The rate of occurrence is (b)(4).This failure mode poses a low risk to the patient because the discolored and rigid cannulae did not prevent the tah-t system from performing tits life-sustaining functions.The cannulae continued to perform as a conduit for air from the external freedom driver to the implanted tah-t.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.

• Brand Name: SYNCARDIA 70CC TAH-T
• Type of Device: BIVENTRICULAR REPLACEMENT DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 5451931
• MDR Text Key: 39218227
• Report Number: 3003761017-2016-00068
• 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
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 02/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 500101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2016
• Initial Date FDA Received: 02/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2012
• 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: 59 YR