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

Model Number VNMF3737C229TU

Device Problems Leak/Splash (1354); Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A valiant navion stent graft system was implanted for the endovascular treatment of a 64mm thoracic aneurysm (275mm in length).The diameter of the proximal neck measured 28mm.Severe vessel tortuosity was noted.It was reported during the index procedure the graft was advanced to the l common carotid.The graft was then deployed and the tip capture handle was released however the tip capture mechanism became stuck on one bare spring or possibly stuck on the proximal edge of the fabric.The device was advanced and withdrawn several times before the tip capture mechanism finally released.The proximal edge of fabric appeared to be affected in turn from this motion and a type ia or type ii endoleak was suspected.Per the physician the cause of the event is undetermined.No additional clinical sequelae were reported and the patient will be monitored.

Manufacturer Narrative

Film analysis summary: the exact cause of the tip capture mechanism becoming stuck on the stent graft during removal of the delivery system, leading to a possible type ia endoleak, could not be determined from the pre-implant films provided.Images during implant and ct¿s post-implant were not available for review, and the reported event could not be assessed.Returned pre-implant ct¿s revealed that the patient had a 53mm max diameter taa at the top of the arch, as well as a 67mm max diameter taa located ~8cm distal to the arch within the proximal portion of the descending thoracic.The thoracic was also severely tortuous distal to these aneurysms.Distal to the planned distal landing zone the thoracic was acutely angulated ~90 deg (horizontal), and a second >130 deg bend was observed within the descending thoracic with associated vessel narrowing to ~18mm at this acute bend.The delivery system was reported as bent in multiple locations after it was removed from the patient; it is likely that the severe vessel tortuosity led to the delivery system kinks which may have been a contributing factor of the removal difficulties.This event is also potentially procedure/user related.A device issue cannot be ruled out as a potential cause.However, the delivery system was discarded and product investigation could not be performed.Additional information: it was reported that the delivery system appeared to be bent in multiple locations after it was removed from the patient, no additional clinical sequalae were reported.It was reported that bailout procedures were not used and that the wire was retracted.It was noted that forward pressure was relieved but that the anatomy was so tortuous that the system had built up forward tension.It was noted that when deploying the suprarenal stents, it appeared that one did not detach from the delivery system.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT NAVION
• 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: 8206356
• MDR Text Key: 131719294
• Report Number: 9612164-2018-03791
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00763000100698
• UDI-Public: 00763000100698
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/18/2019

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: 08/29/2020
• Device Model Number: VNMF3737C229TU
• Device Catalogue Number: VNMF3737C229TU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2018
• Initial Date FDA Received: 12/31/2018
• Supplement Dates Manufacturer Received: 01/07/2019
• Supplement Dates FDA Received: 01/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2018
• 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: 84 YR