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

Model Number VAMF3232C100TE

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2018

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 60mm thoracic aortic aneurysm.It was reported that during implantation of the valiant captivia stent graft at the level of the descending aorta the physician wanted to balloon the stent graft.It is noted that protrusion occurred.It is noted that no further actions were taken.The cause of the event is due to the stent graft structure as per the physician.No additional clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

Film evaluation summary: the exact cause of the reported stent graft ¿protrusion¿ that occurred immediately after implant could not be determined from the images and event details provided.Ct¿s prior to implant were not available for review and a complete assessment of the patient¿s anatomy could not be performed.Ct¿s post-implant were also not provided.Angiograms returned during implant revealed that the patient had a ~6cm taa located along the inner curvature of the arch, beginning ~15mm caudal to the lsa.A valiant captivia device was brought up and positioned just past the lsa; the delivery system was biased along the outer curvature of the arch and was gradually angulated ~90 deg from proximal to distal end of the stent graft.No device issues were seen prior to deployment.Following what appeared to be a normal deployment, final angiogram showed that the valiant had been deployed just caudal to the lsa (which was patent), the taa had been excluded with no obvious endoleaks observed.The stent graft od at the proximal end near covered stent #1 measured~30mm, the stent graft expanded slightly to 32mm at stent ring #2 within the unsupported taa, and just distal to the taa the stent graft od narrowed to 23mm.The stent graft od at the distal end measured 32mm.No stent graft issues were observed during or post -deployment.The device was patent, with no obvious stent graft kinks or any other issues observed.It is likely that the reported protrusion was actually the stent graft expanding within the unsupported section of the taa, which would be an expected occurrence, and it is possible that this expansion was the reason why ballooning was not performed within this stent graft location.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 ; 091708096
• MDR Report Key: 7453487
• MDR Text Key: 106248340
• Report Number: 2953200-2018-00589
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: SI
• 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: 10/03/2018

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: 07/12/2019
• Device Model Number: VAMF3232C100TE
• Device Catalogue Number: VAMF3232C100TE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2018
• Initial Date FDA Received: 04/24/2018
• Supplement Dates Manufacturer Received: 09/10/2018
• Supplement Dates FDA Received: 10/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2017
• 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: 62 YR