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

Model Number VAMF3434C200TE

Device Problems Defective Component (2292); Positioning Problem (3009)

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

Event Date 01/30/2024

Event Type  malfunction  

Event Description

An endurant stent graft was implanted and a valiant captivia stent graft was intended to be implanted during the endovascular treatment of a 420mm dissection.It was noted that the patient went to the emergency department on the previous day due to sudden chest, back, and lower limb pain.Aortic cta showed type b aortic dissection, distal true lumen occlusion of the abdominal aorta, and ischemia of both lower limbs.Because the breach was at the root of the left subclavian artery, ftevar surgery was planned.It was reported that during the index procedure due to ischemia of both lower limbs, a ct could not evaluate the approach situation, the femoral artery pulse could not be palpated, so bilateral femoral artery incision was performed.When incising the bilateral femoral arteries, a small amount of blood flowed out from the left approach but no blood flowed out from the right approach.The main stent was selected on the left approach.The guidewire catheter successfully entered the true lumen for angiography.Enew2424c80ee was firstly deployed in the descending aorta segment (distal restriction), and the delivery system passed through the approach normally and deployed normally.When inserting the main body of vamf3434c200te, the stent delivery system got stuck in the external iliac artery and could not be entered further.After withdrawing the stent system, 8-60/10-80 peripheral balloons were used for pre-dilation successively.An attempt to insert a non-medtronic 24-33 large sheath was unsuccessful.The right approach was then attempted and 8-60/10-80 peripheral balloons were used for pre-dilation successively.Neither the vamf3434c200te main body nor the non-medtronic sheath could enter the body.They were replaced with a the non-medtronic 22-33 large sheath which successfully entered the level of the abdominal aorta.The physician withdrew the large sheath and exchanged the vamf3434c200te main body delivery system, but it still could not enter.When withdrawing the delivery system, a gap was found between the tip head and the outer sheath.Finally, a non-medtronic 34-34-200 (22f) stent was used, and through the 22-33 non-medtronic large sheath was deployed to cover the lsa.The surgery was successfully completed and the patient recovered from ischemia in both lower limbs and the dissection false lumen was isolated.Per the physician the cause of the insertion difficulties were anatomy related.It was noted that the true lumen of the abdominal aortic segment was occluded, and the bilateral common iliac and external iliac lesions were difficult to evaluate.There were severe calcified plaques in the common iliac and external iliac areas on both sides.It was confirmed the delivery system was inspected before use and the gap was caused by insertion into the patient vasculature due to severe calcification.No additional sequelae were reported and the patients is fine.

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.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 difficult to position and the gap formed between the tip and graft cover could not be assessed based on the pre-implant films provided.However, the anatomical characteristic reported to have contributed to the events (i.E.Severe calcification) were confirmed on the images.Procedural angiograms showing attempts to advance the delivery system in the patient were not available, hindering a thorough assessment of the events.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

Product analysis conclusion: the device returned with the external slider in the home position.The stent graft was deployed and was not present with the delivery system.A gap between the tip capture release handle and clamping ring was observed.A gap was present between the graft cover and tapered tip measuring 2mm (specification 1mm).Side port extension returned detached from the barb connector.No evidence of glue visible on base of barb connector.Evidence of glue was visible on side port extension.A longitudinal cut was visible to the surface of the side port extension.As the delivery system returned without the stent graft, the reported positioning difficulties could not be confirmed through analysis.A gap between the graft cover and tapered tip was confirmed through analysis.Detachment of the side port extension tubing was also confirmed.Ruler calibration #1217135.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: 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: 18659714
• MDR Text Key: 334849991
• Report Number: 9612164-2024-00640
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup,Followup
• Report Date: 03/01/2024

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
• Device Operator: Health Professional
• Device Model Number: VAMF3434C200TE
• Device Catalogue Number: VAMF3434C200TE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/07/2024
• Supplement Dates Manufacturer Received: 02/09/2024; 02/27/2024
• Supplement Dates FDA Received: 02/09/2024; 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2022
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 70 KG