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

Model Number VNMC3434C182TJ

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Valiant navion stent grafts were implanted in the urgent endovascular treatment of a unknown sized ruptured thoracic aortic aneurysm.The vnmc3131c182tj was implanted distally and the vnmc34341c182tj was then implanted proximally.It was reported that during the index procedure, after the vnmc34341c182tj delivery system was removed, it was noted by the physician that a sticky "glue" like substance was on the graft cover.The physician commented that it did not seem to be bio prosthetic tissue.It was said that prior to use, when the graft covers hydrophilic coating was activated, the entire graft cover was touched by hand and there was no issue noted at this time.There was no introducer sheath used with the device and it deployed normally.As per the physician the cause of the event can not be determined.No additional clinical sequel were provided and the patient is fine.

Manufacturer Narrative

Product analysis: one photo was received from the account showing material observed on the graft cover post removal from the patient.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: 10470657
• MDR Text Key: 204900603
• Report Number: 9612164-2020-03223
• 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: 10/30/2020

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: 03/20/2022
• Device Model Number: VNMC3434C182TJ
• Device Catalogue Number: VNMC3434C182TJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 08/31/2020
• Supplement Dates Manufacturer Received: 10/05/2020
• Supplement Dates FDA Received: 10/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2020
• 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: 78 YR