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

Model Number	ETLW1628C93E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	07/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant device(s) are: product id: etlw1628c93e, serial/lot #: (b)(4), ubd: 06/23/2017, udi#: (b)(4).Product id: etlw1616c124e, serial/lot #: unknown, ubd: unknown, udi#: unknown.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 treatment of a 110 mm abdominal aortic aneurysm.Heli-fx endoanchors were also implanted during the procedure for prevention of neck dilation.It was reported that approximately three and a half years later the patient presented emergently with bilateral lower abdominal pain and a cta showed a type ib endoleak of the right limb with aneurysm enlargement.A secondary intervention procedure was carried out on and the endoleak was repaired with coil embolization of the right hypogastric artery and right stent graft limb extension with the endurant ii stent graft limbs etlw1616c156e, etlw1616c124e and etlw1616c93e.Intervention was successful and subject was discharged.The event was assessed by the investigator to be possibly related to the endograft.It was also reported that the patient had procedural bleeding the day of the secondary procedure.The estimated blood loss during the reintervention procedure was 50cc but 1u of prbc was given in the or to prevent worsening of chronic anemia and the event was reported to be resolved.The event was assessed by the investigator to be possibly related to the re-intervention procedure.
Additional Manufacturer Narrative
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: 8914228
• Report Number: 9612164-2019-03489
• Device Sequence Number: 1811883
• Product Code: MIH
• UDI-Device Identifier: 00643169467415
• UDI-Public: 00643169467415
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2019

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: 09/17/2017
• Device Model Number: ETLW1628C93E
• Device Catalogue Number: ETLW1628C93E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 08/21/2019
• 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: 68 YR
• Patient Weight: 127