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 7 years, who has used the reliant device for expansion of vascular prostheses 250 times in total over the last 51 months and 30 times over the last 12 months and for temporary occlusion of large vessels 400 times in total over the last 51 months and 45 times over 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 (some haematoma formed because of blood accumulation), embolization with transient or permanent ischemia (small embolic formation in left pulmonary artery), vessel perforation or dissection (dehiscence ofa suture), respiratory failure (patient with ard), entry site infection (infection of the access site), stroke (patient with tia), aneurysm (aneurysm of the access pocket), cardiac events (ami in the system), haemorrhage(some bleeding with transfusions), renal complications (acute kidney failure (akf) on acute renal failure (arf) in 3 patients), death (death after procedure was carried out) and inability to insert guidewire (impossible to insert the guide wire).The physician found the hematoma, embolization with transient or permanent ischemia, aneurysm, cardiac events, haemorrhage somewhat or not at all concerning, vessel perforation or dissection, respiratory failure, stroke, renal complications and inability to insert guidewire somewhat concerning, entry site infection not at all concerning and the death very concerning.The hematoma, respiratory failure, entry site infection, stroke, aneurysm, cardiac events, haemorrhage, renal complications and death events were reported to be not related to the device.Some of the embolization with transient or permanent ischemia, vessel perforation or dissection and inability to insert guidewire events were reported to be device related.During use of the reliant for temporary occlusion of large vessels, the following complications were encountered; entry site infection (infection of the access site), entry site hematoma (haematoma at the access site), cardiac events (systemic ami), hemorrhage (haemorrhage at the access site and transfusions).The physician found these events somewhat concerning or not all concerning (cardiac events).None of these events were reported to be related to the device.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

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: 10028709
• MDR Text Key: 189996591
• Report Number: 9612164-2020-01789
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2020
• 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: 06/03/2020
• 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