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

Model Number REL46

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2017

Event Type  malfunction  

Event Description

An endurant ii stent graft system was implanted in a patient for the endovascular treatment the pre-operative rupture of an aortic fistula.It was noted that the aorto-gastric fistula was spitting up blood and this was a palliative procedure to prevent aortic rupture.It was reported that, during the index procedure, the physician asked that the patient not be intubated until after femoral access was gained.However, anesthesia did not wait and pressure dropped upon intubation.Percutaneous access was gained and a 12fr sheath was inserted.A reliant balloon was inserted and inflated.The physician stated that they would have preferred to remove the balloon prior to deployment of the stent graft, but thought that the patient may bleed out.The stent graft was deployed and pressure stabilized.During removal of the balloon, the balloon caught on the proximal edge of the stent graft and partially folded it back on itself.Imaging was done and determined there was no damage.It was noted the stent graft was ballooned and the rupture was sealed, resolving the event.No additional clinical sequelae were reported and it was noted that the patient would be going home to wait out the final days of unrelated end stage bladder cancer.

Manufacturer Narrative

Corrected information: sex, date of birth.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: paola garnica ; 3576 unocal place; santa rosa, CA 95403 ; 7075661361
• MDR Report Key: 6499049
• MDR Text Key: 72989231
• Report Number: 2953200-2017-00616
• 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: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2017
• Is this an Adverse Event Report?: No
• 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: 03/28/2017
• 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: 65 YR