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

Model Number REL46J

Device Problems Burst Container or Vessel (1074); Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A reliant balloon was used as an accessory device for the endovascular treatment of a patient.An endurant iis stent graft system was implanted in the patient, along with two non-medtronic devices.  it was reported that during inflation of the balloon, after the endurant iis main stent graft was implanted, when apposing to the junction site of main body and the contralateral limb, the reliant balloon made contact with the bare stent of the proximal edge of the contralateral limb.It was reported that a hole in the balloon was then created, and it was not possible to inflate the balloon.The balloon was removed from the patient and ballooning was successfully performed with a new balloon.After it was confirmed that there was no endoleak present, the procedure was completed.Per the physician the cause of the event was the interaction of the balloon with the stent graft, due to the slight dislodgement of the balloon position.No clinical sequelae were reported 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: 9085866
• MDR Text Key: 159119349
• Report Number: 9612164-2019-03976
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2021
• Device Model Number: REL46J
• Device Catalogue Number: REL46J
• Device Lot Number: 0009789740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2019
• Date Device Manufactured: 06/18/2019
• 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: 86 YR