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

Model Number	ETBF3616C145E
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/10/2019
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 ii stent graft system was implanted in a patient for the endovascular treatment of an unknown diameter abdominal aortic aneurysm.It was reported that the endurant ii stent graft system was implanted to repair an endoleak in a non-medtronic stent graft.After deployment of the endurant ii bifurcate, the delivery system was difficult to remove.The physician had deployed the gate, the end of the ipsi-lateral limb and the supra-renal stents, but while removing the delivery system they encountered resistance.It was noted that the delivery system and graft were not near the renal arteries and the nose-cone was down inside the non-medtronic stent graft.The physician confirmed that the ipsilateral lunderquist wire was not trapped inside the cage of the non-medtronic stent graft.The endurant ii stent graft was compressed down inside the non-medtronic stent graft near the distal aorta and in the proximal right common iliac artery.The delivery system could no longer be advanced or withdrawn, and the nose cone could not be recaptured.The patient was then converted to an open repair and the endurant ii stent graft was explanted.As per the physician, the cause of the event was user error.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Additional information: it was reported that the physician said he didn¿t recapture the nose cone <(>&<)> spindle correctly in accordance with medtronic¿s ifu and inadvertently pulled the graft down inside the existing endologix graft into the distal aorta/proximal right common iliac.He said he was unsuccessful trying to re-release and recapture once the graft had been pulled down.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: 9191965
• Report Number: 9612164-2019-04367
• Device Sequence Number: 1879293
• Product Code: MIH
• UDI-Device Identifier: 00613994991034
• UDI-Public: 00613994991034
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2019

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: 08/26/2021
• Device Model Number: ETBF3616C145E
• Device Catalogue Number: ETBF3616C145E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 11/07/2019
• 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: 69 YR
• Patient Weight: 91