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

Model Number VAMF3030C200TJ

Device Problem Leak/Splash (1354)

Patient Problems Infarction, Cerebral (1771); Chest Pain (1776); Death (1802); Low Blood Pressure/ Hypotension (1914); Neurological Deficit/Dysfunction (1982); Brain Injury (2219); Injury (2348); Respiratory Failure (2484); Pseudoaneurysm (2605); Nervous System Injury (2689)

Event Date 12/14/2017

Event Type  Death  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A valiant captivia stent graft system was implanted for the treatment of a type b thoracic dissection.It was reported that prior to this, the patient was admitted to the hospital for a type iiia endoleak with a patent false lumen.During antihypertensive therapy, enlargement of the descending aorta was observed, and total arch replacement was performed.In addition, it was reported that the patient had one other manufacture y-graft implanted for the treatment of a aaa approximately 4 years prior the tevar.It was reported that an unknown type endoleak was detected on angiography and since a type ib endoleak couldn¿t be ruled out, another manufacturers extension was additionally implanted.The physician determined the endoleak to be a type iv based on contrast distribution shown on angiography.It was reported that, approximately 8 days post index procedure, coil embolization was performed for a 20mm pseudoaneurysm that developed in the lower renal artery.It was reported that a ct performed approximately 2 years post index procedure indicated an increasing of the aneurysm size.Although an endoleak was suspected, the type could not be identified by ultrasound or mra.As ct angiography could not be performed, follow up was continued by measuring the aneurysm diameter.It was reported that approximately 2 years and 8 months post index procedure, the patient presented with chest pain, and was admitted for possible impending rupture.The possibility of impending rupture was assessed to be low, and the patient developed cin (contrast-induced neurotoxicity) by the impact of emergency ct angiography.For treatment the patient was transferred to the department of internal medicine.Without performing dialysis, the renal function was returned to the baseline.It was reported that, 1 month later, the patient had similar chest symptoms, and was admitted to the hospital for suspected impending rupture of taa.The aneurysm wall was cut open, and a type iii endoleak was found originating from the anterior side of the valiant stent graft implanted during tevar.Then, the proximal et (elephant trunk) implanted in tar was checked, and the stent graft in the site was removed.After occluding the site, blood supply to the axillary artery was resumed, and the proximal side was anastomosed.A branch of the previously deployed other manufacturers device was also anastomosed, and haemostasis was checked.After that, open distal anastomosis was performed on the distal side using 2 pieces.In the end, the stent graft was anastomosed.Weaning from cpb (cardiopulmonary bypass) was difficult, and pulse pressure could not be obtained.Although epinephrine was used, the native blood pressure was almost zero.The physician decided to use pcps (percutaneous cardiopulmonary support), and femoral cannulation continued to be used.The incision in the chest was closed.It was reported that, the next day, the left chest was opened again to observe inside the thoracic cavity.It was noted that ooze of blood persisted from the aneurysm wall.The aneurysm wall was removed as much as practical.Haemostasis was performed carefully using a haemostatic agent and surgical knife.Bleeding was checked thoroughly from the chest wall to the anastomotic site of the stent graft, and no surgical bleeding was detected.After flushing, the incision in the chest was closed as planned.Although weaning from pcps was considered, wall motion indicated severe hypotension even with the use of epinephrine, and therefore weaning was determined as difficult.Also on tee (transoesophageal echocardiography), a large mass of thrombus was present in the left ventricle possibly affected by apex vent, and the physician determined that active weaning should be avoided at that point.The patient returned to icu with pcps attached.It was reported that, approximately 4 days later, the patient was weaned from pcps and after weaning, the hemodynamic was stable; however, from a head ct performed the next day , global cerebral ischemia was confirmed.It was reported that the patient then developed sinus arrest and global cerebral ischemia led to brain herniation, the brainstem dysfunction was followed by disruption of the respiratory circulation and the patient died two days later.

Manufacturer Narrative

Film evaluation summary; explant and film analysis conclusions: from the examination of the returned devices and clinical information provided, the exact cause of the increasing size taa could not be determined.The four (4) fabric holes seen on the proximal device (vamf3030c200tj) appeared most likely to have been caused by abrasion from the underlying distally implanted device.Although no clear endoleak was seen in the returned films, it is possible that these holes may have been the source of a type iii fabric endoleak which contributed to the taa expansion.These holes may also have been partially covered by tissue/thrombus.The exact cause of the mal-deployment of the proximal stent of the closed web distal device (vamc3838c200tj) occurring during implant could not be determined.It is possible that stent graft oversizing, implanting a 38mm device inside a 30mm device, may have contributed to the non-symmetrical deployment and resulting infolding.This may have also been a procedure related issue.It is also possible that this mal-deployment may have contributed to the observed fabric abrasion, due to potential increased fabric wear associated from the resulting fabric infolding.In addition, the type iii fabric endoleak observed during the laparotomy was reported as originating from the anterior side of the valiant stent graft, which is the same side as the non-symmetrical deployment location seen on the films.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT CAPTIVIA
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway, CA ; 7075917650
• MDR Report Key: 7227664
• MDR Text Key: 98566595
• Report Number: 2953200-2018-00163
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/03/2018

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: VAMF3030C200TJ
• Device Catalogue Number: VAMF3030C200TJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2018
• Initial Date FDA Received: 01/30/2018
• Supplement Dates Manufacturer Received: 03/07/2018
• Supplement Dates FDA Received: 04/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 75 YR