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

Model Number VAMF3636C200TU

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Dyspnea (1816); Necrosis (1971); Pain (1994); Pleural Effusion (2010); Obstruction/Occlusion (2422); Insufficient Information (4580)

Event Date 02/05/2023

Event Type  Death  

Event Description

2 valiant captivia stent grafts were implanted during the endovascular treatment of a 61mm descending thoracic aortic aneurysm on (b)(6) 2016.The stent graft model vamf3636c200tu was implanted proximally and vamc3838c150tu distally.It was noted that there was at least 50mm of overlap between the stent grafts.The patient had an ascending aortic aneurysm treated with ascending and hemiarch replacement performed approximately 4 months previously.It was reported that the patient presented to the emergency department approximately 1 month post the index procedure with complaints of shortness of breath and abdominal distention.A ct scan was performed and revealed right pleural effusion.The patient was then transferred to a different healthcare facility.Over the course of the admission, the patient complained of abdominal pain and distention.The patient was discharged 3 days later.The following day the patient complained of severe abdominal pain, particular in the upper abdomen, which worsened with movement.A ct scan identified the presence of "diffuse air bubbles within the abdomen.There appeared to be pneumatosis within the wall of the stomach.There is free fluid within the air-fluid level in the abdomen¿".The patient was then diagnosed with an acute surgical abdomen.The patient underwent an exploratory laparotomy later on the same day.Approximately 2.5 litres of ascitic fluid was encountered in the left upper quadrant of the patient's abdomen.After irrigating the area, it was noted the presence of a black necrotic gastric wall that was disintegrating with a large hole and necrotic spleen.It was reported that the patient's stomach had "liquified' and the "mucosa of the pylorus and potentially further along into the duodenum was necrotic".A splenectomy, total gastrectomy, duodenostomy tube placement , and abdominal washout with placement of a wound vac were performed.The patient was left in discontinuity with an open abdomen due to septic shock and severe abdominal contamination.Abdominal washouts were performed when the abdomen was closed.After two weeks post gastrectomy, the patient was deemed not a suitable candidate for either esophageal diversion or reanastomosis.The patient was transferred to a different facility for further evaluation and medical management.As per the new evaluation, it was determined that the aortic stent graft had migrated and occluded the celiac artery, causing the gastric and splenic stenosis.Approximately 4 months after presenting, the patient underwent esophageal reconstruction with jejunal interposition graft and a roux-en-y reconstruction, closure of duodenostomy and resection, and placement of jejunal feeding tube.The patient remained hospitalized for a further month.It was reported the patient expired approximately 6 years and 1 month later.No cause of stent migration or death was provided.No additional sequelae was reported and the patient is expired.

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: v amc3838c150tu, serial/lot #: (b)(4), ubd: 28-sep-2016, udi#: (b)(4).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
• 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: 16520043
• MDR Text Key: 311035068
• Report Number: 9612164-2023-01059
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00643169346567
• UDI-Public: 00643169346567
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/10/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2018
• Device Model Number: VAMF3636C200TU
• Device Catalogue Number: VAMF3636C200TU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/10/2023
• Initial Date FDA Received: 03/10/2023
• Date Device Manufactured: 04/20/2016
• 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): Death
• Patient Age: 79 YR
• Patient Sex: Female