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

Model Number	ETLW1616C82E
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Dyspnea (1816); Occlusion (1984); Pain (1994)
Date of Event	06/30/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: etlw1616c82e, sn (b)(4), expiration date: 2016-11-04, (b)(4).Film evaluation summary: the exact cause of the proximal type i endoleak observed during implant could not be determined from the films provided.It is possible that this was anatomy related.The pre-implant ct¿s noted that the proximal neck was short, conical-shaped, and was moderately angulated to 50° maximum.The neck diameter just below the lowest right renal artery measured 25mm, and 10mm lower near the bottom of the neck measured ~31mm.Images during implant revealed that the bifurcate was implanted ~5mm below the renals within the short neck, and a likely proximal type i endoleak was seen coming from the left side of the neck which had minimal stent graft apposition.Multiple endoanchors were then seen implanted primarily on the left-lateral side which appeared to have resolved the proximal type i endoleak.Films at discharge did not reveal any endoleak, however, there was minimal stent graft purchase proximally as well as distally within the left/contra limb.The cause of the reported kinked left limb and leg pain occurring 1-month post-implant could not be determined.The films showing the kink and stent intervention were not available for review.It is unclear if the minimal left limb distal seal length seen within the lcia, and the observed left iliac artery angulation (~90°) and calcification may have contributed to the eventual kink.Patient previous history of lower extremity pad may have also contributed.The cause of the respiratory insufficiency could not be determined.This may be related to the patient¿s pre-existing condition; copd.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 stent graft system was implanted in a patient for the endovascular treatment of a 6.5 cm diameter abdominal aortic aneurysm.Vessel morphology was reported as aortic neck diameter at the renal artery was 25 mm, 20 mm distal to the renal artery the aortic neck is 38 mm in diameter and has 47 degree angulation.It was reported that during the initial procedure there was a proximal type i endoleak present.The physician elected to implant ten aptus endoanchors and the proximal type i endoleak was resolved.On the same day, post-operative the patient experienced respiratory insufficiency resulting in bradycardia and abdominal pain.The patient was given medication and required prolonged hospitalization.The event resolved three days post implant.It is uncertain if the event is related to the procedure or the device.Approximately six weeks post implant the patient presented at a scheduled follow up visit with bilateral leg pain and severe increased velocity in the left iliac.An ultrasound was performed, revealing kinking in the left limb of the endurant stent graft.Lower extremity arterial intervention was performed.Another manufacturer¿s 9x40 bare metal stent was implanted outside of the stent graft.The investigator indicated that the intervention was unrelated to aaa.No additional clinical sequelae were reported and the patient is fine.
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 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: 6370274
• Report Number: 2953200-2017-00311
• Device Sequence Number: 19024860
• Product Code: MIH
• UDI-Device Identifier: 00643169467576
• UDI-Public: 00643169467576
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2017

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: 02/07/2018
• Device Model Number: ETLW1616C82E
• Device Catalogue Number: ETLW1616C82E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Initial Date Received by Manufacturer: 02/06/2017
• Supplement Date Received by Manufacturer: 02/06/2017
• Initial Report FDA Received Date: 03/01/2017
• 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; Disability
• Patient Age: 72 YR
• Patient Weight: 89