MAUDE Adverse Event Report: MEDTRONIC IRELAND VALIANT CAPTIVIA - FF; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number VAMF3430C150TJ

Device Problems Leak/Splash (1354); Obstruction of Flow (2423); Detachment of Device or Device Component (2907)

Patient Problem Perforation of Vessels (2135)

Event Date 02/06/2024

Event Type  Injury  

Manufacturer Narrative

Device evaluation summary: two (2) images were received showing the detached taper tip and the taper tip peek tubing detachment site.The peek material appears bunched and deformed.The break site is jagged and uneven.There was no image of the material removed from the taper tip during device preparation for use.The reported taper tip detachment was confirmed through image review.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.

Event Description

Valiant captivia stent grafts (vamf3430c150tj <(>&<)> vamc2824c150tj ) were implanted during the endovascular treatment of a 15 mm thoracic aortic dissection.It was reported during the index procedure, two issues occurred with the vamf3430c150tj stent graft.During the device preparation , before the device was inserted, it was noted the wire lumen was stiff and could not be flushed.Upon inspection , it was seen that the tip of the tapered was not open and was blocked with the same material that was tip was made from.This material was able to be removed and the device was then able to be flushed.The stent graft was then inserted and implanted.During the removal of the delivery system, the tapered tip detached and could not be removed.The rest of the delivery system was removed and then a non mdt sheath was inserted; from there, the snare was raised to grasp the stiff wire, and then the tapered tip was pushed down to collect it with the non mdt sheath.A dissection then occurred at the right external iliac artery.A bare metal stent was placed to repair the dissection.Per the physician the cause of the events was not identified.No additional clinical sequelae were reported, and the patient is fine.

Manufacturer Narrative

Additional information was received: during the procedure 3 stents of (b)(6), were deployed.A 13mm fenestration from the central end of the graft (the first stent peak) was created and sewed on double markers for embolization and snare.The device was fully deployed.A hole was made in the outer sheath with 16g non mdt catheter and a 25-400 wire was passed through for pre-cannulation.The stent was reloaded by tucking it between the stents with thread and tourniquet.During the last stent, all the captures of the bare stent came off, so about 3 stents were deployed again and the bare stent was re-stored.After all reloading, a groove to fit the wire into the tapered tip was made with a sterile chisel, and the reloading was completed.After placing the (b)(6) in the descending position, the catheter was dropped from the left arm to create a route for the canal wire.The wire lumen was flushed in preparation for inserting the (b)(6), but it was hard and could not be flushed.When the tip of the tip was checked, it was covered with white plastic made of the same material as the tip.The physician then pinched the embolus with his finger and it opened and could then be flushed.(b)(6) was deployed from zone 2, and when it was deployed to fenestration, the balloon set in lsa was advanced, but the lsa wire got caught and did not go smoothly.The physician was able to untangle the wire and everything went smoothly.The main device was placed without any problems, and the non mdt stent was placed in the lsa.When removing the main device, the entire device was lowered to the bottom line and docked.When trying to remove, it was observed that the tapered tip was left behind in the descending line.The physician unplugged the main device and inserted a non mdt the 24fr sheath.The snare was raised from the same side, caught with the stiff wire and pulled the tip down.The physician wanted to put it in the sheath, but because of the difference in level it could not be put inside the sheath so the sheath was pulled at the same time as the wire to collect the tip.At that time, the right eia dissected, and a bare stent was placed.It was noted that no angulation was reported when attempting to remove the device or no excessive force was used that was thought to contribute to the tip detaching.The physician who performed the procedure has worked with valiant grafts and a visiting experienced physician was in attendance for guidance.There were no issues noted with the 2nd stent graft (b)(6).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

Film evaluation summary: the reported tapered tip detachment was confirmed on the angiograms provided, however a cause could not be determined.The reported blockage of the tapered tip , flushing difficulties during preparation and the external iliac artery dissection could not be confirmed on the images, therefore the cause of these events could not be determined.Pre-implant ct¿s were not available for review and a comprehensive assessment of the patient¿s anatomy could not be performed.There were no obvious anatomical considerations such as tortuosity that could have contributed to the reported tapered tip detachment.Analysis of the returned images did not reveal any obvious out of specification stent graft integrity issues.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.

Manufacturer Narrative

Image analysis: two (2) images were received showing the detached taper tip and the taper tip peek tubing detachment site.The tip capture mechanism was off the screw threads on the middle member.The break site appeared jagged and uneven.There was no image of the material removed from the taper tip during device preparation for use.The reported taper tip detachment was confirmed through image review.Product analysis: the delivery system returned with the detached taper tip.The external slider was partially open, and the tip capture release handle was in the home position.The taper tip peek lumen material was flush at the detachment site with no evidence of stretching.Deformation was observed on the graft cover tip and on the stent stop cup material.A 0.035-inch guidewire was passed through the tip without issue.The guidewire was loaded via the luer with a blockage noted in the backend taper tip peek lumen.The handle was disassembled, and severe kinking was observed to the lumen.The grove created during the fenestration was visible on the taper tip.There was no further damage to the taper tip.The tip length was measured at 2.187-inch (pass), specification is 2.162 ¿ 2.212-inch.Fluoroscopy imaging of the taper tip confirmed the peek bulb was correctly positioned, the insert was correctly positioned, and the overmould lumen channel was visible.The tip detachment was confirmed through analysis.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: VALIANT CAPTIVIA - FF
• 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: 18675970
• MDR Text Key: 335012125
• Report Number: 9612164-2024-00704
• 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,Followup,Followup
• Report Date: 05/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VAMF3430C150TJ
• Device Catalogue Number: VAMF3430C150TJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 02/09/2024
• Supplement Dates Manufacturer Received: 02/21/2024; 03/25/2024; 05/14/2024
• Supplement Dates FDA Received: 02/29/2024; 04/17/2024; 05/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2022
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male