MAUDE Adverse Event Report: MEDTRONIC IRELAND VALIANT CAPTIVIA - FF; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number VAMF2828C150TE

Device Problems Break (1069); Detachment Of Device Component (1104); Inability to Irrigate (1337)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2017

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A valiant stent graft system was implanted in a patient for the endovascular treatment of a 300mm thoracic aortic dissection.It was reported that during the index procedure, while trying to flush the valiant stent graft, the connection for the syringe was broken and detached from the delivery system.After this another replacement valiant stent graft was implanted in the patient and the event was resolved.It was reported that no packaging defects were noted prior to use.As per the physician, the cause of the event was due to the detachment of the flush catheter from the delivery system.No additional clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

Device evaluation summary: the device and detached side port were returned for analysis.There was no elongation evident to the side port tubing.The side port extension was broken off at the base of the barbed adaptor.The break point was uneven.There were marks on both sides of the device leading up to the side port.There was deformation visible to on the side port tubing near the break point.It is possible that the damage on the device was could be due shear force experienced on the side port.While the root cause of the side port detachment cannot conclusively be determined, it is possible that the side port was damaged or weakened during the index procedure.As per the physician, the cause of the event was due to the detachment of the flush catheter from the delivery system.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT CAPTIVIA - FF
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway, CA ; 7075917650
• MDR Report Key: 7085952
• MDR Text Key: 93893656
• Report Number: 2953200-2017-01932
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2018

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: Health Professional
• Device Expiration Date: 07/13/2018
• Device Model Number: VAMF2828C150TE
• Device Catalogue Number: VAMF2828C150TE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/19/2017
• Initial Date FDA Received: 12/06/2017
• Supplement Dates Manufacturer Received: 04/16/2018
• Supplement Dates FDA Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2016
• 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: 38 YR
• Patient Weight: 85