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

Model Number ETCF2525C49EE

Device Problem Device Expiration Issue (1216)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2017

Event Type  malfunction  

Manufacturer Narrative

Failure to follow instruction: implant of expired product.If information is provided in the future, a supplemental report will be issued.

Event Description

An expired endurant ii cuff was implanted in a patient for the proximal extension of a previous endovascular treatment.It was noted that the product was taken out of consignment by the medtronic sales rep and was no longer on the shelf but was standing in the physician's office between demo/expired products and was inadvertently used.No additional clinical sequelae were reported.

Manufacturer Narrative

Additional information received for this case reported that the physician confirmed the patient received the cuff as a protection against and osteo synthetic screw (protrusion) in the lower part of the thoracic aorta.The physician stated this was an off-label use of the device.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II EXTENSION CUFF
• 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: ibrahim ibrahim ; 3576 unocal place; santa rosa, CA 95403 ; 7075917650
• MDR Report Key: 7036325
• MDR Text Key: 93035274
• Report Number: 2953200-2017-01795
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2016
• Device Model Number: ETCF2525C49EE
• Device Catalogue Number: ETCF2525C49EE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2017
• Initial Date FDA Received: 11/16/2017
• Supplement Dates Manufacturer Received: 11/20/2017
• Supplement Dates FDA Received: 12/11/2017
• Date Device Manufactured: 11/25/2014
• 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