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 Problem Death (1802)

Event Type  Death  

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 8 years, who has used the reliant device for expansion of vascular prostheses 20 in total over the last 5 months and for temporary occlusion of large vessels 40 times in total over the last 5 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; vessel perforation or dissection (vessel rupture after stunt implantation), paresthesia (sensitivity disturbances after procedure), stroke (neurological deficit after the procedure), aneurysm (expansion of the vessel walls after the procedure), haemorrhage (bleeding after the procedure), death (complications after the procedure), malposition (under or over -expansion after stent implant).The physician found the vessel perforation or dissection, aneurysm, death events very or somewhat concerning, paresthesia, stroke, malposition events very concerning, haemorrhage events not at all concerning, death (complications after the procedure), malposition (under or over-expansion after stent implant).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; stroke (neurological deficit after procedure), aneurysm rupture (vascular perforation after notified aneurysm), haemorrhage (bleeding in a vessel with complications), death (death after stent implant).The physician found the stroke, aneurysm rupture and death events somewhat or not at all concerning and the haemorrhage events very or not at all concerning.The aneurysm rupture events were reported to be not related to the device, all of the other 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

It was reported that during the use of the reliant for expansion of vascular prothesis, the physician also encountered aneurysm ruptures (edge dissection on already implanted stent).The physician found these events very concerning, somewhat concerning and not at all concerning.These events were reported to be related to the device itself on at least one occasion.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: 10009130
• MDR Text Key: 189317939
• Report Number: 9612164-2020-01716
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2020
• 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