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

Model Number VAMF4444C200TJ

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aneurysm (1708); Seroma (2069)

Event Date 03/24/2016

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: vamf4440c150tj sn (b)(4), expiration date: (b)(6) 2018, udi # (b)(4), vamf4646c200tj sn (b)(4), expiration date: (b)(4) 2017, udi # (b)(4).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 implanted in a patient for the endovascular treatment of a 6.0 cm thoracic aortic aneurysm.The patient had an aortic arch replacement at some point prior to the index procedure.An elephant trunk tevar was performed and another manufacturer's stent graft was also implanted during the index procedure.Approximately eight months post index procedure it was noted that the distal side of the valiant device had become aneurysmal.The physician elected to implant two additional valiant devices that had to be implanted above the celiac artery.It was noted that there were no junctional leaks.The patient remained under observation after this procedure.The aneurysm then began growing larger increasing the risk of rupture.A left thoracotomy was performed and all the valiant devices, as well as part of the other manufacture¿s device, were explanted.A blood vessel prosthesis was then implanted.The physician stated that the cause of the event was a seroma that began to appear from an unknown location; it was unknown if the stent graft was related to the seroma.The patient was stable, recovering and no additional intervention was required.No additional clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

Corrected information: sex, date of birth.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: 6498242
• MDR Text Key: 72950974
• Report Number: 2953200-2017-00608
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/17/2017

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2015
• Device Model Number: VAMF4444C200TJ
• Device Catalogue Number: VAMF4444C200TJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2017
• Initial Date FDA Received: 04/17/2017
• Supplement Dates Manufacturer Received: 03/24/2017
• Supplement Dates FDA Received: 10/17/2017
• Date Device Manufactured: 11/12/2013
• 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: 67 YR