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

Model Number AB46

Device Problems Burst Container or Vessel (1074); Migration or Expulsion of Device (1395); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 fol lowing 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 arterosclerosis), 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 arterosclerosis), 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

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.Method/result conclusion updated.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: 10003995
• MDR Text Key: 192164261
• Report Number: 9612164-2020-01695
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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
• Initial Date Manufacturer Received: 04/06/2020
• Initial Date FDA Received: 04/28/2020
• Supplement Dates Manufacturer Received: 05/18/2020
• Supplement Dates FDA Received: 06/15/2020
• 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