MAUDE Adverse Event Report: MEDTRONIC IRELAND RELIANT STENT GRAFT BALLOON CATHETER -OUS; CATHETER, PERCUTANEOUS

Model Number REL46J

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

Patient Problem Intimal Dissection (1333)

Event Date 03/03/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A reliant balloon was used in conjunction with a non - mdt stent graft in the endovascular treatment of a abdominal aortic aneurysm and the right common iliac aneurysm.It was reported that during the index procedure when performing the deployment on the proximal side of main body of the non-mdt stent graft, the proximal end of this device was implanted slightly obliquely.After all the devices were implanted, ballooning was performed for the whole device with a reliant balloon.It was reported that it would be better if ballooning was performed only once, but the diameter and number of expansion were not excessive.After that, ballooning was performed again on the proximal side of the main body with the same balloon, when the proximal side of main body was checked by imaging, the dissection near the proximal edge of main body was suspected.A non-mdt aortic cuff was additionally implanted on the proximal side of the implanted main body to repair the dissection.Contrast examination showed disappearance of blood flow in the dissected cavity.As per the physician the cause of the event is unknown but was not considered procedural or a product issue.No additional clinical sequalae were provided and the patient is fine.

Manufacturer Narrative

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

• Brand Name: RELIANT STENT GRAFT BALLOON CATHETER -OUS
• Type of Device: CATHETER, PERCUTANEOUS
• 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: 9852951
• MDR Text Key: 184060411
• Report Number: 9612164-2020-01232
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: REL46J
• Device Catalogue Number: REL46J
• Device Lot Number: 0009990394
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2020
• 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 Outcome(s): Other
• Patient Age: 80 YR