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

Model Number REL46

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

Patient Problems Death (1802); Vascular Dissection (3160)

Event Date 03/29/2017

Event Type  Death  

Manufacturer Narrative

The main component of the system.Other relevant device(s) are: rel46.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A heli-fx endoanchor system was implanted in a patient for the endovascular treatment of a ruptured abdominal aortic aneurysm.It was noted that endoanchors were used prophylactically due to the extremely angulated neck.There was no evidence of calcium.It was reported that, during the index procedure, one of the anchors ¿jumped¿ during the second stage.The anchor initially looked ok and had penetrated the stent graft and cuff.However, it was then noticed that the ¿d¿ piece of the anchor was floating up.The physician advanced the guide and aspirated the piece out of the patient.It was then reported that, during the repair, anesthesia could not control the patient¿s hemodynamics.A transesophageal echocardiography was done and a retrograde dissection and paracardial effusion were identified.The surgery was stopped and the case was aborted.The patient died as a result of the dissection, which extended to the aortic root.The physician stated that they did not think that the endurant stent graft cause the dissection; instead it was thought that it was due to the cross clamp, occlusion balloon, wire manipulation.The physician also stated that the cause of the endoanchor break was product related.No additional clinical sequelae were reported.

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: paola garnica ; 3576 unocal place; santa rosa, CA 95403 ; 7075661361
• MDR Report Key: 6501382
• MDR Text Key: 73076208
• Report Number: 2953200-2017-00629
• 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: 03/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 03/29/2017
• 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 Outcome(s): Death
• Patient Age: 65 YR