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

Model Number VAMF3030C150TE

Device Problems Inability to Irrigate (1337); Component or Accessory Incompatibility (2897)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2017

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A valiant captivia stent graft system was selected for use in a patient for the endovascular treatment of a thoracic aortic aneurysm.It was reported that the wire channel of the delivery system was blocked and the device could not be flushed and a wire could not be fed through.Another valiant device was used to complete the procedure.The physician stated the cause of the event cannot be determined.No clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

Further investigation confirmed that no leak was observed coming from the handle during the procedure.The leak that was found during analysis occurred from a split in the taper of the barb adapter that most likely occurred during returned shipment.The split in the barb adapter prevented the delivery system from being able to be fully irrigated during analysis however, it is unknown why irrigation could not be completed during the procedure.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Device evaluation summary: the inability to irrigate complaint was confirmed; there was a leak between the barbed adaptor and side port extension which made irrigation difficult.The root cause of the event could not be conclusively determined.The device was sent to (b)(4) for further review (possible mfg assessment).The steering wire complaint could not be confirmed; the wire passed through the device with no issue.

Manufacturer Narrative

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: paola garnica ; 3576 unocal place; santa rosa, CA 95403 ; 7075661361
• MDR Report Key: 6612843
• MDR Text Key: 76720870
• Report Number: 2953200-2017-00923
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/20/2017

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: 12/08/2018
• Device Model Number: VAMF3030C150TE
• Device Catalogue Number: VAMF3030C150TE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2017
• Initial Date FDA Received: 06/05/2017
• Supplement Dates Manufacturer Received: Not provided; 06/20/2017; 06/20/2017
• Supplement Dates FDA Received: 06/15/2017; 06/30/2017; 10/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2016
• 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