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

Model Number VNMC3737C223TJ

Device Problems Difficult or Delayed Positioning (1157); Flaked (1246); Device Damaged by Another Device (2915); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2020

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 was attempted to be implanted in a patient for the endovascular treatment of a 71*75 mm thoracic aneurysm.It was reported that during the index procedure, the first access was made via left common femoral artery (cfa), plain old balloon angioplasty were performed but the device could not be inserted.Approach was made via right cfa, (blood vessel prosthesis implantation was already performed), poba was also performed and the device was managed to be passed through.It was reported that the device was caught on another device and could not pass the abdominal branch level.The device was then removed and an attempt was made to change the route with balloon, but the device could not pass through.As per the physician, cause of the event was patient's anatomy.It was reported that the patient's had a poor passage due to very narrow access and previously implanted device.It was also reported that the cause of the event was possibly related to the peeling of the coating, which was stuck in external iliac artery.No additional clinical sequelae were reported and the patient will be monitored.

Manufacturer Narrative

Additional information received: it was reported when the valiant navion interacted with the other device, there was no damage caused to the valiant as a result.It was said that the device was attempted to be delivered many times and the approach was changed from left to right.It was thought then this affected the smoothness of the delivery system and made it difficult to deliver and position.H6:updated film evaluation summary: the reported difficult to position event was not confirmed on the films provided.Lack of procedural angiograms showing the difficulties in inserting the device via the access vessels and the interaction with other device were not provided.It is likely that the patient¿s narrowed access vessels in addition to the previously implanted devices may have been contributory factors in the events reported.A device issue appears to be unlikely but the delivery system was discarded and a product investigation could not be performed.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: VALIANT NAVION
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 10501226
• MDR Text Key: 206120231
• Report Number: 9612164-2020-03381
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2022
• Device Model Number: VNMC3737C223TJ
• Device Catalogue Number: VNMC3737C223TJ
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/03/2020
• Date Manufacturer Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 91 YR