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

Model Number ETBF2316C166EJ

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Reaction (2414)

Event Date 06/20/2018

Event Type  Injury  

Manufacturer Narrative

Medtronic received the following information obtained from the journal article entitled; a case of nickel allergy after endovascular aortic repair yohei kawatani, hirotsugu kurobe, yoshitsugu nakamura and takaki hori doi: 10.1177/0218492318784736 journals.Sagepub.Com/home/aan.Other relevant device(s) are: etlw1613c124ee; serial number unknown; use by date unknown; upn# unknown.Etlw1620c93ee; serial number unknown; use by date unknown; upn# unknown.Etlw1620c82ee; serial number unknown; use by date unknown; upn# unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

An endurant ii stent graft system was implanted in the patient for the endovascular treatment of a 61mm diameter abdominal aneurysm rupture.The following adverse events were observed: allergic reaction.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II BIFURCATED STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway,ie
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway,ie
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 7693365
• MDR Text Key: 114141632
• Report Number: 2953200-2018-01036
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2018

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
• Device Operator: Health Professional
• Device Model Number: ETBF2316C166EJ
• Device Catalogue Number: ETBF2316C166EJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2018
• Initial Date FDA Received: 07/17/2018
• Supplement Dates Manufacturer Received: 08/08/2018; 10/25/2018
• Supplement Dates FDA Received: 10/03/2018; 10/25/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR