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

Model Number	ETBF3216C145E
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/16/2020
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 bifurcate stent graft system was implanted in the endovascular treatment of a 50mm abdominal aortic aneurysm.It was reported that the patient presented emergently almost six weeks later with a diminished pulse in the right groin and leg.A ct was preformed and found there was limb compression in the gate of the right limb of the bifurcate device.It was confirmed by ivus there was no compression present in the stent graft limbs etlw1620c124e or etlw1616c124e.The left limb of the device was found to be placed at the flow divider while the right limb was placed approximately 2.5-3cm below the flow divider.The compressed portion of the right limb measured 4mm by intravascular ultrasound.The patient was brought to or where a 16-16-93 endurant limb was placed from the right side and was aligned equal to the limb that was on the left side.Two 14mm kissing balloons were inflated at the flow divider.Post procedure intravascular ultrasound showed equal limbs measuring 9mm by 13mm.It was reported that the patients blood flow immediately restored to the right leg.As per the physician the cause of the event can not be determined.No additional clinical sequalae were provided and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary: the reported compression of the bifurcate ipsi/right limb was confirmed.This appears most likely related to implanting within the small diameter (22 ¿ 25mm) and long proximal neck; the opposing contra limb within the overlapping gate appeared to have compressed the ipsi limb near its origin just below the flow divider.It is also likely that the acute neck angulation at this location exacerbated the limb compression.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: 9615867
• Report Number: 9612164-2020-00378
• Device Sequence Number: 16280579
• Product Code: MIH
• UDI-Device Identifier: 00613994990983
• UDI-Public: 00613994990983
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2020

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: 11/21/2020
• Device Model Number: ETBF3216C145E
• Device Catalogue Number: ETBF3216C145E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Initial Date Received by Manufacturer: 01/17/2020
• Supplement Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 01/22/2020
• Supplement Report FDA Received Date: 03/02/2020
• 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: 84 YR