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

Model Number ESBF2814C103E

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Reaction (2414)

Event Date 07/12/2017

Event Type  Injury  

Manufacturer Narrative

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 Description

An endurant iis stent graft system was implanted in a patient for the endovascular treatment of a 53 mm diameter abdominal aortic aneurysm.The endurant stent grafts were successfully implanted.It was reported that the patient called the physician¿s office with complaint of a couple of itchy spots on one leg and was told to monitor it and follow up if it got worse.The patient called later and said that the spots have turned to little blisters and covered the patient from his hips to their feet bilaterally.The patient was instructed to come into the office and was seen.The patient was treated with antibiotics/steroid and the visible symptoms have subsided.Biopsy of two of the lesions were taken and showed antibodies generally present in a "rejection" reaction.The physician stated the cause of the event is suspected to be from an allergic reaction but not 100% sure.No additional clinical sequelae were reported and the patient will be monitored by their physician.

• Brand Name: ENDURANT IIS BIFURCATED STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: paola garnica ; 3576 unocal place; santa rosa, CA 95403 ; 7075661361
• MDR Report Key: 6792446
• MDR Text Key: 82623009
• Report Number: 2953200-2017-01278
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00643169439979
• UDI-Public: 00643169439979
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/20/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 05/25/2019
• Device Model Number: ESBF2814C103E
• Device Catalogue Number: ESBF2814C103E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2017
• Initial Date FDA Received: 08/14/2017
• Date Device Manufactured: 05/25/2017
• 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: 68 YR