MAUDE Adverse Event Report: MEDTRONIC IRELAND RELIANT BALLOON; CATHETER, PERCUTANEOUS

Model Number REL46

Device Problem Device Damaged by Another Device (2915)

Patient Problem Injury (2348)

Event Date 07/08/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

An endurant iis stent graft system was implanted in a patient for the endovascular treatment of an 66 mm abdominal aortic aneurysm.It was reported during the index procedure the patient became hypotensive after groin perc access closure was completed.Wire access was achieved, and a run showed extravasation of dye from the left limb.It was reported that this was not initially recognised during the final angio run but was apparent when the angio was repeated.The physician relined the left limb with an additional endurant 16 mm limb with sealing achieved per the physician the cause of the event was anatomy related due to calcification.It was reported that the it is probable that ballooning of the stent graft with a reliant balloon ruptured a calcium plaque that likely tore the fabric of the stent graft.No additional 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 BALLOON
• 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: 8850143
• MDR Text Key: 152913623
• Report Number: 9612164-2019-03175
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REL46
• Device Catalogue Number: REL46
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 82 YR