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

Model Number ETEW2828C82EJ

Device Problems Leak/Splash (1354); Malposition of Device (2616); Activation, Positioning or Separation Problem (2906)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/20/2024

Event Type  malfunction  

Manufacturer Narrative

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.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

Valiant captivia stent grafts (vamc2424c150tj, and vamc2626c150tj ) and a endurant limb extension ( etew2424c82ej) were implanted to treat a 400mm type b aortic dissection.The dissection onset was nineteen days earlier and there was noted to be partial false lumen thrombosis.It was reported during the index procedure, zone 3 tevar was performed. following the placement from just above the celiac artery to just below the left subclavian artery (etew2424c82ej), (vamc2424c150tj) and (vamc2626c150tj) were implanted in order from the peripheral end.A type iiia endoleak occurred due to insufficient length in the peripheral junctions.The type iiia endoleak occurred from the junction of (etew2424c82ej) and (vamc2424c150tj).During treatment of the iiia endoleak, after a 18f sentrant sheath was inserted, the endurant extension (etew2828c82ej) was delivered, but a defect occurred immediately after the deployment commenced.After deploying the proximal 2 stents, attempts were made to deploy the trigger but the trigger remained stiff and could not be pulled, resulting in a deployment failure.The physician attempted to quickly deploy the trigger several times but was unsuccessful.However, this caused the endurant extension (etew2828c82ej) to shift from its intended position to the periphery due to being pushed.No problem was noted with the physician's implantation procedure / deployment maneuvers which confirmed that (etew2828c82ej) was not accidentally deployed in the sentrant 18 fr.It was decided that continuing using the trigger for deployment posed risks of delivery system damage and further migration.Consequently, deployment was switched to using an external slider, and implantation was successfully completed.Although the endurant extension (etew2828c82ej) had migrated from the scheduled placement position to the peripheral region, the purpose of the junction strengthening was ac hieved, and the type iiia endoleak disappeared.Post operatively, when the delivery system was removed the trigger was tested and seemed to work without issue.It was confirmed although the (etew2828c82ej) had migrated from the planned location, it was genera lly in placed in the expected range.The deployment of this stent graft was followed per the ifu and there was no damage noted to the device itself or packaging prior to use.There was no issue noted with the sentrant sheath per the physician the cause of the deployment issue was not specified.The cause of the type iiia endoleak was due to insufficient length but there was no issue with the sizing of the stent graft or the specifications of the stent grafts.No additional clinical sequelae were provided, and the patient is fine.

Manufacturer Narrative

Product analysis conclusion: the reported deployment difficulty and inaccurate delivery could not be confirmed on the pre-implant image available, therefore, the cause of the event could not be determined.Procedural angiograms showing the deployment of the stent graft were not available for review.Lack of complete pre-implant cts were not available for a thorough assessment of the pre-implant anatomy but from the limited image available, there was no obvious anatomical characteristics that may have contributed to the reported events.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.

• Brand Name: ENDURANT II ILIAC STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• 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: 18873115
• MDR Text Key: 337732349
• Report Number: 9612164-2024-01187
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ETEW2828C82EJ
• Device Catalogue Number: ETEW2828C82EJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2023
• 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: 70 YR
• Patient Sex: Male