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

Model Number VAMF3636C200TE

Device Problem Leak/Splash (1354)

Patient Problems Anemia (1706); Disseminated Intravascular Coagulation (DIC) (1813); Thrombocytopenia (4431)

Event Date 09/28/2021

Event Type  Injury  

Manufacturer Narrative

Medtronic received the following information from a journal article entitled; persistent disseminated intravascular coagulation despite correction of endoleaks after thoracoabdominal endovascular aneurysm repair kim et al, journal of vascular surgery cases, innovations and techniques volume 7, issue 4, p730-733, december 01, 2021.Https://doi.Org/10.1016/j.Jvscit.2021.08.012.Other relevant device(s) are: vamf3636c150te; s/n: unknown; use by date: unknown; upn # unknown.Vamf3632c150te; s/n: unknown; use by date: unknown; upn # unknown.Vamf4040c200te; s/n: unknown; use by date: unknown; upn # unknown.Vamf3636c200te; s/n: unknown; use by date: unknown; upn # unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Valiant stent grafts were implanted in a patient during the endovascular treatment of a type b aortic dissection with a 5-cm distal thoracic aneurysm on an unknown date.It was reported approximately 11 months post the index procedure aneurysmal degeneration of the perivisceral aorta was diagnosed.Reno-visceral debranching using non mdt grafts (14 x 7-mm expanded polytetrafluoroethylene [eptfe] graft from the left common iliac artery to the left renal artery and superior mesenteric artery and a 12 x 6-mm eptfe graft from the right common iliac artery to the right renal artery and common hepatic artery) was performed.Two weeks later a left common carotid to left subclavian artery bypass grafting with a non mdt (eptfe) and a distal tevar extension using 36x32x150 and 150x40x40 valiant stent grafts with extensive overlap.Follow up ct one year later demonstrated a type ib endoleak.A distal tevar extension with 36x36x200 valiant stent grafts were implanted down to the distal abdominal aorta, however, 8 months later, follow-up cta showed both a type ia endoleak and a type iii endoleak.An ascending aortoeinnominate and left carotid bypass grafting with proximal extension tevar was planned.However, during a cardiac evaluation for the planned operation, the patient was found to be anaemic and thrombocytopenic.After several months of investigations a diagnosis of disseminated intravascular coagulation (dic) was made secondary to a persistent endoleak.The patient underwent intervention where an ascending aorta to innominate and left carotid artery bypass grafting and concomitant proximal tevar extension with a 37 x37 x220-mm valiant navion stent graft.The completion angiogram showed no evidence of an endoleak.By postoperative day (pod) 7, she had normalization of fibrinogen and aptt with stabilization of the platelet count.However, h er d-dimer levels remained elevated.She was discharged on pod 15.Approximately 3 months later the patient presented with a 3-day history of haematuria.Hematology workup indicated dic exacerbation.A cta demonstrated a large type iii endoleak.The existing stent grafts were relined from the proximal descending to the distal abdominal segments with two 37 x 37 x 220-mm navion stent grafts with complete resolution of the type iii endoleak.After haematology values normalised the patient was discharged to a rehabilitation facility on pod 8 and to home 1 week later.Nine months later, a follow up ct identified a new type iii endoleak with expansion of the aneurysm sac.A further intervention - tevar with coverage of the leaking segment using a non mdt was performed.During follow-up, resolution of the previous endoleak on cta at 3, 6, and 9 months after surgery was noted.Laboratory studies showed a persistently elevated values leading to a diagnosis of chronic dic with compensation.Per the physician the cause of the type ib and type iii endoleaks are undetermined.The chronic dic was considered likely due to the presence of persistent type i and type iii endoleaks, with high flow vascular channels leading to fragmented red blood cells and coagulation activation.No additional clinical sequelae were reported 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: 13567539
• MDR Text Key: 287406176
• Report Number: 9612164-2022-00697
• Device Sequence Number: 1
• Product Code: MIH
• 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: Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/21/2022

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 Model Number: VAMF3636C200TE
• Device Catalogue Number: VAMF3636C200TE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2022
• Initial Date FDA Received: 02/21/2022
• 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
• Patient Age: 77 YR
• Patient Sex: Female