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 Intimal Dissection (1333); Embolism (1829); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Blood Loss (2597)

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 8 years, who has used the reliant device for expansion of vascular prostheses (assisting in the expansion of self-expanding stent grafts) 40 times in total of which 15 times were in the last 12 months.For the temporary occlusion of large vessels the physician used the device 50 times in total, of which 20 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; blood loss/ bleeding (from the access site, failure of the closing mechanism) , haemotoma (retropetoneal haematoma, patient with unfavourable femoral anatomy, stabilised after heparin suspension, 1 transfusion bag), embolization (micro or macro) with transient or permanent ischemia (temporary ischaemia dx lower limb) , vessel perforation or dissection (common iliac artery dissection emerging with the reliant, resolved with stent), entry site infection (obese patient, diabetic, with poor personal care.Cutaneous infection in the inguinal fold over 7-10 days), entry site hematoma (hematoma to 12 f vascular access) , stroke (retinal tia, resolved by itself), emboli (distal embolism resolved by itself) hemorrhage (from the access site, failure of the closing device).The physician found the blood loss/bleeding events not at all concerning, the hematoma events very concerning and somewhat concerning and not at all concerning.The embolization events somewhat concerning, the vessel perforation or dissection events somewhat concerning, the entry site infection and hematoma not at all concerning, the stoke very concerning, the emboli somewhat concerning and the hemorrhage not at all concerning.The embolization, vessel perforation or dissection and emboli were considered to be related to the device on at least once occasion each.During use of the reliant for temporary occlusion of large vessels, the following complications were encountered; parathesia (temporary, lower limbs, adamkiewicz), entry site infection (localised cutaneous infection), entry site haemtoma (12 f access.Resolved with compression and confinement to bed ) and renal complications (post-op acute kidney failure, acute tubular necrosis from hyper perfusion).The physician found the parathesia event was somewhat concerning, the entry site infection and haemotoma not at all concerning, the renal complications somewhat concerning and not at all concerning.The parathesia and renal complications events were deemed to be related to the device itself.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: 10013006
• MDR Text Key: 194472141
• Report Number: 9612164-2020-01721
• 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: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2020
• 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: 06/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention