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

Model Number REL46

Device Problem Device Damaged by Another Device (2915)

Patient Problem Injury (2348)

Event Date 08/03/2017

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

An endurant ii stent graft system was implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm.The left iliac artery measured 11-12-11mm in diameter with mild calcification.The right iliac artery measured 10-12-13mm in diameter with mild calcification.The distal aorta was approximately 20mm in diameter it was reported that the final angiogram showed what appeared to be a blush in the right proximal common iliac.The physician stated there was heavy calcification in the proximal right common iliac.A reliant balloon had been used in the same area as the leak which may have contributed to the event.The physician stated that the event is anatomy related (calcification).Another endurant ii limb was implanted, resolving the endoleak.No additional clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

Film review: the cause of the reported blush seen coming from the proximal portion of the right common iliac artery could not be determined from the limited films provided.Analysis of the returned films did not reveal any device characteristics that could explain the reported event.The complete anatomy at implant could not be assessed, and other than a single image after the devices had been implanted, no additional films during implant were available.Images during ballooning were also not provided.It is possible that the reported ballooning within the heavily calcified iliac artery may have led to a fabric tear and type iii fabric endoleak.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: ibrahim ibrahim ; 3576 unocal place; santa rosa, CA 95403 ; 7075917650
• MDR Report Key: 6827067
• MDR Text Key: 83874204
• Report Number: 2953200-2017-01350
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REL46
• Device Catalogue Number: REL46
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention
• Patient Age: 78 YR