MAUDE Adverse Event Report: MEDTRONIC IRELAND RELIANT STENT GRAFT BALLOON CATHETER -US; CATHETER, PERCUTANEOUS

Model Number AB46-US

Device Problem Device Damaged by Another Device (2915)

Patient Problem Injury (2348)

Event Date 03/27/2018

Event Type  Injury  

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 a 92mm ruptured abdominal aortic aneurysm.A 90-degree tortuosity near the flow divider in the proximal area of the bifurcate was noted.It was reported during the index procedure the left main body 28-16-145 was inserted from the left arm and implanted using the pull through technique.On the contralateral right side, the limbs 16-24-124 and 24-24-82 were additionally implanted.A remaining 7 cm was observed on the ipsilateral left side so a 16-20-93 was further implanted.Asg (stent graft) balloon catheter was used to dilate the ipsilateral left side.While dilating the right cia (common iliac artery) using the sg balloon with a (12-fr dryseal) sheath, the physician felt something unusual in balloon manipulation and suspected a possible presence of thrombus.While dilating the proximal area from the right side the patient's blood pressure dropped(according to the anaesthesiologist, the blood pressure started to decrease gradually during balloon dilation in the right cia.) dsa (digital subtraction angiography) was performed from the arch to the eia (external iliac artery).Vessel damage was observed in the right eia near the bifurcation to the iia (internal iliac artery).No endoleak or other issues were noted.The physician then elected to extend the stent graft coverage to the right eia while keeping the right cia occluded using the sg balloon.While attempting to balloon proximally the sheath was so tight that the reliant was unable to advance through it.Another manufactures sheath was used however the reliant became stuck at the proximal tortuous site, and further delivery toward the proximal region was impossible.An attempt with a stiff guidewire (gw) was used however it could not advance proximally.An angiogram was performed at this time which revealed that the 16-20-93, which was additionally implanted on the ipsilateral side, was disengaged from the distal leg of the main body.Another attempt was made and a gw was successfully delivered through the disengaged limb and leg using a snare, and the left side was repaired by implanting an additional limb 16-20-124 preserving theleft limb.It was also observed on angiogram that the right distal limbs (24-24-82 and 16-24-124) implanted earlier had also disengaged.A 16-10-199 limb was implanted but coverage was inadequate and a 10-10-82 limb was additionally implanted.Final angiography revealed the procedure was successful.Per the physician the cause of the event was anatomy related due to fragile blood vessels.The physician commented that in addition to the decreased blood pressure and the post-pull through process, the stent grafts had been mispositioned as if they were floating.In this situation, the gw was pulled out, and then the balloon catheter was delivered multiple times from the distal area.As a result, the stent grafts were disengaged.No additional clinical sequelae were reported and the patient is fine.

• Brand Name: RELIANT STENT GRAFT BALLOON CATHETER -US
• 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: 7453474
• MDR Text Key: 106246918
• Report Number: 2953200-2018-00587
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AB46-US
• Device Catalogue Number: AB46-US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2018
• 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: 94 YR