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

Model Number	ETBF2813C145E
Medical Device Problem Codes	Malposition of Device (2616); Activation, Positioning or Separation Problem (2906); Device Damaged by Another Device (2915)
Health Effect - Clinical Codes	Occlusion (1984); Renal Failure (2041)
Date of Event	02/13/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of a 5 cm in diameter abdominal aortic aneurysm.It was reported that the physician intentionally inserted another manufacturer¿s 7 fr.90 cm sheath through the left brachial artery down to the left renal artery, to implant another manufacturer¿s covered stent into the left renal artery and land proximal to it at the right one.He then cannulated the left renal artery with a glidewire and placed a 7 mm x 38 mm covered stent into it.The physician then deployed the endurant bifurcated stent graft and the endurant contra limb.The physician then deployed the supra renal stent while inflating the balloon to expand the covered stent to the nominal diameter.The endurant bifurcated stent graft was ballooned at the proximal end while keeping the covered stent balloon inflated.Both the balloons were deflated.The physician attempted to retract the 7fr sheath but it would not move, due to the suprarenal stent anchor pins that were embedded in it.As the 7fr sheath was pulled back the endurant stent graft moved proximal.The physician was unable to withdrawal the covered stent ball oon through the 7 fr sheath.The radiopaque marker on the 7fr sheath was caught on the suprarenal stent anchors pins of the endurant stent graft.The 7 fr sheath would neither move proximal or distal.The physician inflated both the reliant balloon in the endurant stent graft proximal aortic neck and the other manufacturer¿s covered stent balloon.The physician attempted to push the sheath forward, was unsuccessful, and then it pulled back.The 7 fr sheath and the covered stent pulled back into the dta (descending thoracic aorta), with the covered stent still on the balloon.Then the covered stent balloon was pushed distal into the endurant bifurcated stent graft and snared it.The covered stent balloon was withdrew out of the right groin, however the covered stent dislodged from the balloon into the right iliac ipsilateral limb.The catheter of the covered stent balloon was cut and removed it from the left arm.The angiogram revealed that the covered stent was in the right limb and verified via ivus.The physician elected to implant a 10 mm x 38 mm covered stent into the endurant ipsilateral limb and inflated, crushing the smaller covered stent in place, and then over dilated with a 12 mm balloon.The physician attempted but was unable to re-cannulate the left renal artery behind the endurant stent graft.An angiogram revealed that there are no endoleaks, but the left renal artery was occluded.The physician cannot determine the exact cause of the event, however it was related to the interaction of the devices.No additional clinical sequelae were reported and the patient will be monitored by their physician.
Additional Manufacturer Narrative
Corrected information: sex, date of birth.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II BIFURCATED STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6393179
• Report Number: 2953200-2017-00357
• Device Sequence Number: 16456728
• Product Code: MIH
• UDI-Device Identifier: 00613994991294
• UDI-Public: 00613994991294
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/17/2018
• Device Model Number: ETBF2813C145E
• Device Catalogue Number: ETBF2813C145E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/13/2017
• Supplement Date Received by Manufacturer: 02/13/2017
• Initial Report FDA Received Date: 03/09/2017
• Supplement Report FDA Received Date: 09/29/2017
• 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: Required Intervention
• Patient Age: 75 YR