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

Model Number VAMF4242C100TE

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

Patient Problems Adult Respiratory Distress Syndrome (1696); Hemothorax (1896)

Event Date 06/08/2021

Event Type  Injury  

Manufacturer Narrative

Medtronic received the following information obtained from the journal article entitled; endovascular repair of ruptured type b aortic dissection r.Miri et al, jmv-journal de médecine vasculaire, volume 46, issue 4, 2021, pages 186-189,issn 2542-4513, https://doi.Org/10.1016/j.Jdmv.2021.05.006.Implant date unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

A valiant captivia stent graft system was implanted in a patient for the treatment of a ruptured type b aortic dissection.One the day after operation, the patient presented with signs of respiratory distress with pulmonary compression.Via left thoracotomy, a hemothorax evacuation was performed.The patient had an uneventful recovery and was discharged seven days after the operation.A one-month cta control showed a well-positioned aortic prosthesis, total thrombosis of the false lumen without endoleak or extension of the dissection.Per the physician the cause of the respiratory distress is undetermined.No additional clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

B5: additional information received: per the physician the complications were pre existing and not related to the implanted valiant stent graft.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 TR
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 12405693
• MDR Text Key: 269298000
• Report Number: 9612164-2021-03370
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

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 Expiration Date: 05/23/2019
• Device Model Number: VAMF4242C100TE
• Device Catalogue Number: VAMF4242C100TE
• Device Lot Number: V07410878
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/16/2021
• Initial Date FDA Received: 09/01/2021
• Supplement Dates Manufacturer Received: 09/05/2021
• Supplement Dates FDA Received: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR