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

Model Number ETLW1620C93E

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/29/2022

Event Type  malfunction  

Event Description

An endurant ii stent graft was intended to be implanted in a patient for the endovascular treatment of a 54mm abdominal aortic aneurysm.It was reported during the index procedure when the box for the ipsilateral 124mm endurant limb intended to be implanted was opened it was discovered the incorrect graft (146) was inside.When boxes for two 93mm limbs were opened they contained packaging for a 146mm limb.When the contralateral limb was implanted it was noted when the packaging was opened to be a 124 limb, however when the stent was put in the body it was discovered it was actually a 93 limb based on the sticker on the delivery system.The endurant limb etlw1620c93e ((b)(4)) was noted when opened to contain a 124 limb.The patient received treatment using additional available grafts (2 x 124 limbs) and the procedure was successfully completed.Per the physician the cause of the event is undetermined.It was noted that the boxes were opened when looking for the appropriate size for the patient.No additional clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: e tlw1620c146e, serial/lot #: (b)(4), ubd: 30-may-2024, udi#: (b)(4); product id: etlw1620c93e, serial/lot #: (b)(4), ubd: 11-may-2024, udi#: (b)(4); product id: etlw1620c146e, serial/lot #: (b)(4), ubd: 30-may-2024, udi#: (b)(4).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

Manufacturer Narrative

Additional information received: it was confirmed that the 146 limbs were contained in 93 boxes: etlw1620c93e sn (b)(6) contained etlw1620c146e sn (b)(6) and etlw1620c93e.Sn (b)(6) contained etlw1620c146e sn (b)(6).A box for a 124 limb size was opened and during the procedure it was confirmed to contain a 93 limb inside.Device evaluation summary: 3 photos of the delivery system were received via email in gch on 03-aug-2022.Image0.Jpeg, d10: updated continuation of d10: section d information references the main component of the system.Other relevant device(s) are: etlw1620c93e s/n: unknown; use by date: unknown; upn # unknown etlw1620c124e s/n: unknown; use by date: unknown; upn # unknown medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: ENDURANT II ILIAC STENT GRAFT
• Type of Device: 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: 15082201
• MDR Text Key: 304299938
• Report Number: 9612164-2022-02777
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00643169467514
• UDI-Public: 00643169467514
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/29/2022

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: 05/11/2024
• Device Model Number: ETLW1620C93E
• Device Catalogue Number: ETLW1620C93E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 07/22/2022
• Supplement Dates Manufacturer Received: 08/03/2022
• Supplement Dates FDA Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2022
• 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 Age: 76 YR
• Patient Sex: Male