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

Model Number AB46

Device Problems Burst Container or Vessel (1074); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/13/2019

Event Type  malfunction  

Manufacturer Narrative

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.It was reported that patient had aneurysm growth without evidence of any endoleak.An intervention procedure was carried out approximately fours years and nine months later and an endurant stent graft cuff etcf3232c49e, endurant stent graft limb etlw1620c93e and endurant stent graft limb etlw1613c93e were implanted in the patient as treatment.It was reported that no endoleak was seen during the procedure.The patient then presented with abdominal pain approximately one month later and ct showed an endoleak that appeared to originate above the flow divider of the original bifurcated stent graft.The general area of the endoleak was confirmed by angio during an intervention procedure carried out the following day.It was reported that an endurant aui device was implanted as treatment.It was also reported that ballooning was then carried out with a reliant balloon, however the reliant balloon burst when in the area above the flow divider.Further angio showed that contrast appeared to be leaking into the original bifurcated stent graft and into the aneurysm sac.It was reported that it was believed that there may have been a stent fracture that caused the endoleak, and burst the reliant balloon and tore the endurant aui device that had just been placed.As per the physician, the cause of the event cannot be determined.No additional clinical sequelae were reported and the patient is being monitored.

Manufacturer Narrative

Film evaluation summary: the exact cause of the events could not be determined from the films provided.The anatomy at implant is unknown, and earlier post-implant films were not provided for comparison.Review of angiograms during an intervention 57 months post-implant confirmed no endoleak or any other stent graft integrity issues, and ct¿s from 58 months post-implant confirmed aaa expansion and a likely type iiib fabric endoleak coming from near the bifurcate aortic body, between the level of the aortic cuff and flow divider.The exact cause of the endoleak could not be determined, but appears possibly related to fabric abrasion from aortic calcification adjacent to the endoleak location.The reported possible stent fracture could not be confirmed, and it is unclear why the type iiib endoleak was not observed during the angiogram 1 month prior.However, implanting the aortic cuff (with ballooning) at that time may have exacerbated the tear.The cause of the reported reliant balloon burst and aui fabric tear also could not be determined.Films during implant of the aui were not available for review.It is possible that over-ballooning may have led to the burst and the reported fabric tear.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: 9104354
• MDR Text Key: 159616974
• Report Number: 9612164-2019-04031
• 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: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2019
• 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 Age: 70 YR