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

Model Number	ETLW1628C124E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant device(s) are: product id: e tlw1616c82e, serial/lot #: (b)(4), ubd: 21-dec-2017, udi#: (b)(4).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 75mm abdominal aortic aneurysm.It was reported that the patient presented emergently with pain approximately three years and three months later and ct showed an endoleak and increase in aneurysm size.After ruling out a type ii endoleak the patient was brought to the operating room where the graft was assessed.A type iii endoleak was observed from the left side from the stent graft limbs (b)(4).There was no leak on the right side.An additional stent graft limb etlw1616c156e was placed at the flow divider and extended to the flared portion of the 28mm limb on the left side.After ballooning, a final angiogram showed that the endoleak had resolved.As per the physician, the cause of the event cannot be determined.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Product analysis conclusion: the reported endoleak can be confirmed by the films provided; however the type of cause of the endoleak cannot be confirmed.Lack of returned angiography images showing the endoleak, which may have included possible endoleak interrogation, did not permit a more comprehensive analysis of the endoleak source/cause.Post-implant ct¿s showing the stent graft in-vivo configuration at the index procedure were not provided for assessment and comparison.Although a type iiib fabric endoleak cannot be ruled out, this appears most likely to have been a type iiia junctional endoleak.It is possible that the aneurysm morphology changes, such as the angulated neck and limbs and increased aneurysm expansion, may have contributed to a limb separation, resulting in a type iiia endoleak.Insufficient stent graft overlap length at implant (which could not be confirmed) may have also contributed to the limb detachment.The junctional separation occurred within the aaa sac; therefore, lack of vessel support may have also been a factor.Analysis of the films did not show any obvious stent graft issues that may have led to the reported endoleak.Additional information: it was confirmed the endoleak was type iiib, coming from the left limb distal to the gate marker.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: 9847370
• Report Number: 9612164-2020-01209
• Device Sequence Number: 19575077
• Product Code: MIH
• UDI-Device Identifier: 00643169467453
• UDI-Public: 00643169467453
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2020

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: 10/05/2018
• Device Model Number: ETLW1628C124E
• Device Catalogue Number: ETLW1628C124E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 04/10/2020
• 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: 80 YR
• Patient Weight: 87