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

Model Number	ETBF3216C145E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	02/22/2019
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 of a 52 mm abdominal aortic aneurysm.After the bifurcated stent graft, two limbs and an aortic cuff were implanted a small endoleak was noted on the patient¿s right side, directly above the flow divider.The physician decided to re-balloon with a reliant, however, another arteriogram still showed the endoleak in the same place.A pigtail catheter was then placed inside the graft and another intra-operative arteriogram was performed.The endoleak again appeared in the same place.As per the physician, the endoleak was either a type iv or a type iiib.The physician, then decided to place two additional limbs etlw1616c93e on the right and etlw1616c124e on the left approximately 2cm above the flow divider, try and utilize more fabric inside the bifurcated stent graft.Two reliant balloons were placed inside the limbs and the kissing technique was carried out to fully expand the limbs.However during inflation, the patient¿s blood pressure dropped.An intra-operative arteriogram was performed, and extravasation was noticed near the renal arteries which demonstrated a rupture of the aorta.The physician then decided to perform an open repair to fix the rupture.It was reported that none of the stent grafts were explanted.As per the physician, the cause of the event was due to the patient¿s thin and diseased aortic arterial wall.No additional clinical sequelae were reported and the patient is fine.

• 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: 8366572
• Report Number: 2953200-2019-00268
• Device Sequence Number: 19311544
• Product Code: MIH
• UDI-Device Identifier: 00613994990983
• UDI-Public: 00613994990983
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 02/25/2019

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: 09/26/2019
• Device Model Number: ETBF3216C145E
• Device Catalogue Number: ETBF3216C145E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 02/25/2019
• 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: 75 YR