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

Model Number UNK-CV-SR-VAL-CAP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Anemia (1706); Stroke/CVA (1770); Fever (1858); Hematoma (1884); Ischemia (1942); Pleural Effusion (2010); Local Reaction (2035); Renal Failure (2041); Obstruction/Occlusion (2422); Vascular Dissection (3160)

Event Date 04/25/2022

Event Type  Injury  

Event Description

59 patients with complex aortic arch pathologies underwent endovascular or concomitant hybrid surgery over a two year period.The patients were operated on for type b aortic dissection , aortic ulcer, intermural aortic hematoma, and thoracic aortic aneurysm.Fourteen patients received hybrid surgery, and the other 45 underwent branched surgery or fenestrated surgery.During the hybrid procedures 2 patients received a valiant captivia stent graft while in the endovascular procedures, 4 patients were implanted with a valiant captivia stent graft.There was 100% operative success achieved.The following malfunctions were reported; endoleaks the following adverse events were reported; hematoma, cerebral infraction, numbness/ischemia, dissection, occlusion, allergic reaction, anemia, fever, renal failure, pleural effusion, paraplegia, pulmonary effusion patient mortality was reported but there is no causal link that a valiant stent graft caused or contributed to any deaths.

Manufacturer Narrative

Medtronic received the following information from a journal article entitled; mid-term outcomes of endovascular and hybrid procedures to treat complex aortic arch pathologies li p, bi j, niu f, chen j, dai x, zhu j, hu f.Journal of endovascular therapy 2023 oct;30(5):682-692 doi: 10.1177/1526602822109189 a.2.A.3 average.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 UNK
• 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: 17984488
• MDR Text Key: 326247267
• Report Number: 9612164-2023-04784
• 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,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/23/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: UNK-CV-SR-VAL-CAP
• Device Catalogue Number: UNK-CV-SR-VAL-CAP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 10/23/2023
• 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): Other; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male