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

Model Number VAMF4440C150TJ

Device Problems Difficult to Remove (1528); Positioning Problem (3009)

Patient Problem Perforation of Vessels (2135)

Event Date 04/08/2024

Event Type  Injury  

Manufacturer Narrative

Product analysis conclusion: the reported removal difficulties and vessel damage could not be confirmed on the pre-implant films provided; therefore, the cause of the events could not be determined.Lack of complete pre-implant ct's did not allow for a thorough assessment of the pre-implant anatomy.Moreover, the pre-implant films available did not depict the access vessels.Procedural angiogram videos showing attempts to remove the device were not available for assessment of the reported events.Product analysis #804246169:one (1) partial image of the delivery system was received.Material is visible on the graft cover over the stent stop.The graft cover appears to be partially flattened/deformed distal to the stent stop.The removal difficulties were confirmed through image review.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 Description

A valiant captivia vamf4440c150tj stent graft was implanted during the endovascular treatment of an 56mm thoracic aortic aneurysm.At the time of implantation, the access vessel diameter was approximately 7 mm with no tortuosity or calcification.It was reported during the index procedure, there was difficulty inserted the vamf4440c150tj (25fr/8.3mm) and non-mdt sheath into the right access vessel, leading to the physician switching to left approach.Despite encountering resistance, the devices passed through, and a zone 3 tevar was placed according to the standard procedure with rapid pacing.The delivery system was then docked on the celiac.It was noted that (vamf4036c150tj) was standing by for use as a replacement, but the valiant captiva delivery system (vamf4440c150tj) became stuck.Attempts to remove it by ballooning with a non mdt balloon failed, resulting in the vessel being pulled out.To prevent major bleeding as it was removed , the patient's abdomen was opened through a medical incision, exposing the peripheral aorta to the center of the eia.An artificial vessel was placed in the right cia, a non-mdt sheath (24fr) was inserted, and an additional valiant captivia stent graft (vamf4036c150tj was implanted.Touch-up was performed and no endoleaks were observed.Upon removal of the non-mdt (18fr dry seal) from the right eia, the patient's blood pressure dropped, revealing extensive damage to the right eia.Attempts to repair it with non mdt stent was not enough to cover the damage, necessitating the removal and reinsertion of the wire before an additional stent could be inserted.However, during insertion, the center of the vbx was outside the vessel due to the physician's unawareness that the wire had exited the vessel through the damaged area.The repair of the right eia was abandoned, a bypass was made from the left cia to the left cfa with a further bypass from the left cfa to the right cfa, restoring blood flow to the lower extremity.Subsequently, the valiant captiva delivery system (vamf4440c150tj) stuck in the left eia was successfully removed.Wounds were closed, and the procedure was completed.Per the physician the cause of the delivery systems removal difficulties was due to a patient's vascular morphology, where the access was about 7 mm, which was thinner compared to the device.It could not be confirmed whether there was any damage to the delivery system prior to use.The deployment steps had been followed per ifu.No additional clinical sequelae were provided, and the patient will be monitored.

• Brand Name: VALIANT CAPTIVIA - FF
• 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: 19151224
• MDR Text Key: 340678954
• Report Number: 9612164-2024-01922
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100040
• 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
• Report Date: 04/22/2024

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 Expiration Date: 04/19/2024
• Device Model Number: VAMF4440C150TJ
• Device Catalogue Number: VAMF4440C150TJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2022
• 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): Required Intervention; Other
• Patient Age: 89 YR
• Patient Sex: Female