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 Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Tingling (2171); Rupture (2208); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 25 years, who has used the reliant device for expansion of vascular prostheses 200 times in total of which 35 of those times were in the last 12 months.For the temporary occlusion of large vessels the physician has used it 75 times in total of which 25 of those times were 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; allergic response to materials (very strong sensitivity from the start of the first procedure, sometimes requiring adrenaline to administer), hematoma (it always occurs, but to varying degrees, and is difficult to control), vessel perforation or dissection, paresthesia (it continues after the procedure for several days and returns spontaneously), entry site infection (it happened several times, and in one of them the patient was to go into toxic shock, it was reported that antibiotic coverage should be considered before the procedure), entry site hematoma, stent graft migration caused by balloon catheter device, inability to insert guidewire, (because of the sometimes formed hematoma), balloon rupture (it occurred several times spontaneously and inexplicably).The physician found the allergic response to materials, haemtoma and vessel perforation or dissection events very concerning, somewhat concerning and not at all concerning.The parathesia events somewhat concerning and not at all concerning, the entry site infection very concerning and somewhat concerning, the entry site haematoma events very concerning, not at all concerning and somewhat concerning.The stent graft migration, inability to insert guidewire and the balloon rupture were found to be somewhat concerning and not at all concerning, all of the events were reported to be related to the device on at least one occasion.During use of the reliant for temporary occlusion of large vessels, the following complications were encountered; vessel perforation or dissection (it happened two or three times, but can be easily bypassed), entry site hematoma (it usually occurs, but to varying degrees ), aneurysm rupture ( torn when starting to enter on two occasions unexplained and irreversible), hemorrhage (in several cases) , inability to inflate/deflate balloon (it almost caused a fatal problem for the patient), balloon rupture (the rupture is at the beginning of the procedure).The physician found the vessel perforation or dissection, entry site hematoma, aneurysm rupture and hemorrhage events very concerning, somewhat concerning and not at all concerning.The inability to inflate/deflate balloon very concerning and somewhat concerning.The balloon rupture somewhat concerning, very concerning and not at all concerning.All of the events were reported to be related to the device on at least one occasion each.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

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: 10025594
• MDR Text Key: 196943765
• Report Number: 9612164-2020-01776
• 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: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• 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: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1