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

Model Number ESBF3614C103EE

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 05/17/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

An endurant iis stent graft system was received by a sales rep for use in endovascular procedures in patients on an unknown date.It was reported that the label on the device was incorrect, showing a catalogue number and serial number for an endurant iis bifurcate but the diagram of the device does not match the catalogue number device type.The cause of the event is unknown.There was no patient involvement in this event.

Manufacturer Narrative

Additional information received; it was confirmed that the mislabeling issues was first noted by mdt supply chain staff in the mdt offices prior to the device being sent to the facility.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product evaluation: inspection of the shelf carton label confirmed the graft diagram was incomplete.The product details on the label were correct.The pouch label was correct with the complete graft diagram.The cause of the misprint could not be determined through analysis.If information is provided in the future, a supplemental report will be issued.

• 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: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 8686000
• MDR Text Key: 147611447
• Report Number: 9612164-2019-02269
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/12/2019

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: 01/21/2021
• Device Model Number: ESBF3614C103EE
• Device Catalogue Number: ESBF3614C103EE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Initial Date Manufacturer Received: 05/17/2019
• Initial Date FDA Received: 06/11/2019
• Supplement Dates Manufacturer Received: 05/29/2019; 07/17/2019
• Supplement Dates FDA Received: 06/25/2019; 08/12/2019
• Date Device Manufactured: 01/26/2019
• 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