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

Model Number	ENBF2313C166E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994); Rupture (2208); Blood Loss (2597)
Date of Event	05/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant device(s) are: product id: enlw1613c124e, serial/lot #: (b)(4), ubd: 12-jan-2014, udi#: (b)(4).(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant bifurcate stent graft system was implanted in the endovascular treatment of a >50mm abdominal aortic aneurysm.It was reported that the patient presented emergently on the 8 years and 3 months later with complaints of abdominal pain.A ct performed revealed a hematoma and laboratory diagnostic tests confirmed the patient was experiencing blood loss consistent with a ruptured aneurysm.There was no endoleak visible.Intervention was performed on the same date and a non-mdt stent graft was implanted as treatment.As per the physician the cause of the event can not be determined.No additional clinical sequelae were reported and the patient will be monitored.
Additional Manufacturer Narrative
Evaluation summary: the reported ruptured aneurysm was not confirmed on the films received; therefore the cause of the event could not be determined.Lack of pre-implant ct¿s did not allow for a thorough assessment of the pre-implant anatomy.Endoleak interrogation via selective angiograms (injecting from different levels within the stent graft) to help determine the source and rule out other potential endoleak sources was not seen.The cause of the patients abdominal pain and blood loss could not be determined but rupture of the aneurysm could not be ruled out.No obvious stent graft integrity issues were observed on the films provided.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT 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: 10162272
• Report Number: 9612164-2020-02230
• Device Sequence Number: 17037355
• Product Code: MIH
• UDI-Device Identifier: 00613994762313
• UDI-Public: 00613994762313
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/23/2013
• Device Model Number: ENBF2313C166E
• Device Catalogue Number: ENBF2313C166E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2020
• Initial Date Received by Manufacturer: 05/28/2020
• Supplement Date Received by Manufacturer: 06/26/2020
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 07/24/2020
• 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: Other; Required Intervention
• Patient Age: 74 YR