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

Model Number REL46J

Device Problems Burst Container or Vessel (1074); Compatibility Problem (2960)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2019

Event Type  malfunction  

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

A reliant stent graft balloon was used in conjunction with a non mdt stent graft system (afx) during the endovascular treatment of an unknown size abdominal aortic aneurysm.It was reported during the index procedure the reliant balloon ruptured when it came in contact with the stent graft.Per the physician the cause of the rupture was suspected to be related to the stent graft and commented that the stent graft used has an internal skeletal structure and there is a stent inside the graft.No additional clinical sequelae were reported and the patient is fine.

• 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: 9213555
• MDR Text Key: 170792211
• Report Number: 9612164-2019-04442
• 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: 11/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REL46J
• Device Catalogue Number: REL46J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2019
• 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