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

Model Number AB46

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

Patient Problems Stroke/CVA (1770); Hematoma (1884); Hemorrhage/Bleeding (1888); Perforation (2001); Rupture (2208)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess performance of the reliant device.The exact size of the device is unknown.Survey results from an interventional cardiologist in practice 21 years, who has used the reliant device for expansion of vascular prostheses 600 times in total over the last 15 months and 300 times in the last 12 months and for temporary occlusion of large vessels 400 times in total over the last 15 months and 200 times in the last 12 months.During use of the reliant for expansion of vascular prostheses (assisting in the expansion of self-expanding stent grafts), the following complications were encountered; hematoma (very old patients with very fragile case or difficult puncture), vessel perforation or dissection (very old patients), stroke (patient with a lot of arteriosclerosis), haemorrhage(anticoagulated or very old patients), death (very dilated aneurysms), balloon catching inside of graft during catheter movement (complex procedure) and balloon rupture (a lot of calcium in the vessel).The physician found the death events very concerning, hematoma events were somewhat or not at all concerning, vessel perforation or dissection, stroke, balloon catching inside of graft during catheter movement and balloon rupture very or somewhat concerning and the haemorrhage events to be very, somewhat or not at all concerning.All of the adverse events and the balloon catching and balloon rupture events were reported to be related to the device on at least one occasion, the death events were reported to be not related to the device.During use of the reliant for temporary occlusion of large vessels, the following complications were encountered; vessel perforation or dissection (very old, complete anatomy), stroke (significant arteriosclerosis), aneurysm rupture (very dilated aneurysm), death (significant comorbidity), stent graft migration caused by balloon catheter device (significant calcification).The physician found the death events very concerning, vessel perforation or dissection, aneurysm events very, somewhat or not at all concerning, stroke, stent graft migration very or somewhat concerning.All of the events were reported to be related to the device on at least one occasion.Of the above complications reported, some of these are listed as having been reported to medtronic previously.Due to limited information these are included in reporting.No further information has or will be provided.

Manufacturer Narrative

B:5 additional information received.It was reported that during the use of the reliant for expansion of vascular prothesis, the physician also encountered aneurysm ruptures (these were patients with calcified vessels).The physician found these events very concerning, somewhat concerning and not at all concerning.These events were found to be related to the device on at least one occasion.H:6 updated medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: RELIANT BALLOON
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 10003991
• MDR Text Key: 196863876
• Report Number: 9612164-2020-01694
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K050038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AB46
• Device Catalogue Number: AB46
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other