MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDURANT IIS BIFURCATED STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR

Model Number	ESBF3614C103E
Medical Device Problem Codes	Leak/Splash (1354); Malposition of Device (2616)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	09/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant iis bifurcate stent graft system was implanted in the endovascular treatment of a 64mm abdominal aortic aneurysm.  it was reported that during the procedure, the endurant iis bifurcate ((b)(4)) stent graft was inserted via the right common femoral artery.The device wouldn't transverse the calcified iliac arteries.  the physician then used a dilator to dilate and performed a balloon angioplasty.The same device was then tried to be inserted once again, but was not able to pass through the calcified vessels.The physician then inserted a bare metal stent within the right external iliac artery to open up the calcified area. a 9mm x 59mm non mdt stent (non mdt) was utilized and inflated multiple times with a 10mm and 12mm balloon.Then the physician  took a new endurant bifurcate (#(b)(4)) and this was inserted without issue.The stent graft then deployed without issue, the contralateral gate was cannulated and contralateral limb was advanced over a stiff wire.  then an endurant limb (v30578676) was advanced within the left common iliac artery but could not be advanced past the proximal common iliac due to the calcified arteries. the left common iliac was then ballooned but the device still would not pass following this due to the calcified artery.  the physician then deployed the rest of main body device 36mm 14mm x 103.During the tip recapture technique, the spindle and taper tip kept getting caught on suprarenal fixation which was bringing the device down and pulled the device down 1.5cm from the renal arteries.The  main body stent graft then got caught at the proximal rt common iliac artery and subsequent rotation and pulling caused a  ruptured right common iliac artery.The physician stated that anatomy, calcified bifurcation was reason for rupture.   a reliant balloon was inflated within the infrarenal neck for control and a 16mm x 10mm 124 limb was deployed to tamponade the ruptured iliac artery.A 16mm x 13mm x 124mm was utilized to complete the lcia with no issue.Due to the main body stent graft coming down, a type ia endoleak occurred so a endurant cuff was utilized to seal this endoleak followed by balloon molding with reliant balloons.  final angiogram showed a late type ii endoleak.The patient left the or in a stable position.  as per the physician the cause of the event were anatomy related due to calcified iliacs as well as access vessels and not device related.No additional clinical sequalae were provided and the patient is fine.

• Brand Name: ENDURANT IIS BIFURCATED STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 12538867
• Report Number: 9612164-2021-03704
• Device Sequence Number: 19853625
• Product Code: MIH
• UDI-Device Identifier: 00763000306359
• UDI-Public: 00763000306359
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/13/2022
• Device Model Number: ESBF3614C103E
• Device Catalogue Number: ESBF3614C103E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 89 YR