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

Model Number	ETLW1613C156E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2019
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 iis stent graft system was implanted in a patient for the endovascular treatment of a 57mm diameter abdominal aortic aneurysm.There was mild proximal neck, and left and right iliac, calcification present.It was reported that during the index procedure the main body stent graft and two endurant limbs were successfully implanted.However an endoleak was noted on follow up angiogram.After additional imaging, the physician stated that the leak appeared to be a type iiib fabric leak originating from a hole in the 16x13x156 limb.An additional 16x13x124 endurant limb was then successfully implanted, on the same day, to reline the 16x13x156 limb and resolve the endoleak.The physician decided to end the procedure and do a follow up in 30 days.It was reported that the patient presented for follow up on (b)(6) 2019, a ct scan showed no signs of endoleak.As per the physician, the cause of the event was a hole in the fabric of the stent graft limb.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary: the exact cause and source of the endoleak reported during implant could not be determined from the pre-implant films provided.Images during implant were not available for review and the reported endoleak could not be assessed.Post-implant ct¿s were also not provided for a stent graft in-vivo evaluation.A returned pre-implant ct-3d film report revealed that the patient had a short (12mm) length neck, that ranged in diameter from 20 ¿ 23mm.The neck was extensively calcified.The common iliacs were also calcified bilaterally; the left common iliac was mildly tortuous, while the right common iliac was non-tortuous.Other than the calcification seen within the proximal neck and iliac arteries, analysis of the returned films did not reveal any anatomical characteristics that could help explain the reported event.A potential type iiib endoleak may have been caused by aggressive ballooning within a calcified section of the anatomy; however, aggressive ballooning was not reported.While a type iii fabric endoleak cannot be ruled out, this would most likely have been an acute type iv blush endoleak caused by fabric porosity.Other factors such as heparin dose, outflow resistance, and volume of the aneurysm sac may have also contributed to this potential type iv endoleak.The reported additional type ii endoleak may have also been a source of the original endoleak thought to have been a type iii fabric endoleak.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II ILIAC STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8243515
• Report Number: 2953200-2019-00090
• Device Sequence Number: 16695151
• Product Code: MIH
• UDI-Device Identifier: 00643169467583
• UDI-Public: 00643169467583
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 02/11/2019

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: 09/11/2020
• Device Model Number: ETLW1613C156E
• Device Catalogue Number: ETLW1613C156E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Initial Date Received by Manufacturer: 01/08/2019
• Supplement Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 01/14/2019
• Supplement Report FDA Received Date: 02/11/2019
• 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: 71 YR
• Patient Weight: 86