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

Model Number VAMF2828C100TE

Device Problem Folded (2630)

Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)

Event Date 12/05/2017

Event Type  Injury  

Event Description

A valiant captivia stent graft system was implanted in the patient for a thoracic endovascular treatment.It was reported that approximately 2 years post the index procedure the patient returned for follow up ct exam.It was observed that there was a discrepancy in diameter size between the proximal and distal portion of the stent graft with the completely expanded part of the stent graft facing the lesion.There was an observed discrete fibrin deposition at the end of the stent graft which was already known of and was stable.It is reported that the event has been resolved, has not and will not receive treatment.No additional clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

Additional information received; there was no diameter reduction in the distal area of fibrin deposition already noted but the discrepancy was between the proximal and distal part of the prosthesis.The patient was put on aspirin therapy.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: 7192814
• MDR Text Key: 97667728
• Report Number: 2953200-2018-00089
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Type of Report: Initial,Followup
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2017
• Device Model Number: VAMF2828C100TE
• Device Catalogue Number: VAMF2828C100TE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2017
• Initial Date FDA Received: 01/16/2018
• Supplement Dates Manufacturer Received: 03/29/2018
• Supplement Dates FDA Received: 04/09/2018
• Date Device Manufactured: 09/15/2015
• 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): Required Intervention
• Patient Age: 17 YR
• Patient Weight: 69