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

Model Number	ETLW1613C93E
Medical Device Problem Codes	Material Deformation (2976); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
An endurant ii stent graft limb (etlw1613c93e) was intended to be implanted in an unknown endovascular procedure.It was reported via technical services on 18-jun-2024, an email from mdt representative, stated that the endurant ii stent graft limb (b)(6) was scrapped.Additional comments indicated: "open, not used: full charge / open not used | customer | device was damaged upon implant." it was confirmed the box was sealed when taken off the shelf.It was noted that the device was kinked at the tapered tip and graft cover transition.It was reported that the tapered tip and graft cover transition was caught on the patient's skin at insertion site.Only the tapered tip entered the patient.The physician was holding device at the back of the delivery system upon insertion instead of closer to the proximal end for more leverage.The physician removed the delivery system and then used a hemostat to spread the skin for a better transition and advanced a new device without issue.It was confirmed that the delivery system kinked upon insertion into the patient.There was no calcification, the issue was user/procedure related.It was said the physician did not have appropriate leverage upon insertion therefore the device hung on the patients skin.No additional sequelae were reported and the patient is fine.

• Brand Name: ENDURANT II ILIAC STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 19701758
• Report Number: 9612164-2024-03168
• Device Sequence Number: 11666658
• Product Code: MIH
• UDI-Device Identifier: 00643169467682
• UDI-Public: 00643169467682
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/09/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/29/2026
• Device Model Number: ETLW1613C93E
• Device Catalogue Number: ETLW1613C93E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 07/09/2024
• Date Device Manufactured: 01/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Male