MAUDE Adverse Event Report: MEDTRONIC MEXICO EUPHORA RX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY,

Model Number EUP2515X

Device Problem Material Deformation (2976)

Patient Problems Aneurysm (1708); Vascular Dissection (3160)

Event Date 08/09/2022

Event Type  Injury  

Manufacturer Narrative

Title: unusual interventional treatment of a complex calcified coronary artery lesion in a child with kawasaki disease: a case report.Authors: anthony mézier, claire dauphin, géraud souteyrand, and pascal motreff.Journal name: european heart journal - case reports year: 2022 reference: doi: 10.1093/ehjcr/ytac332, b3: date of publication.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

A journal article was submitted for review titled "unusual interventional treatment of a complex calcified coronary artery lesion in a child with kawasaki disease: a case report".This case study is of a child with kawasaki disease (kd), who had undergone revascularization by percutaneous coronary intervention (pci) on calcified chronic total occlusion (cto) of the right coronary artery (rca) and the management of complications.At four years old the patient presented with kd which was complicated by coronary aneurysm of the proximal left anterior descending (lad) artery and ectasia of the rca.These lesions progressively calcified and resulted at the age of 13 in chronic occlusion of the rca.At the age of 13, the patient was asymptomatic, with normal left ventricular function, but a stress echocardiography test demonstrated ischaemia in the large inferior territory of the left ventricle.Coronary aneurysm (ca) of the lad with intermediate stenosis upstream of the aneurysm, and cto of the rca was observed.After evaluation and discussion by the heart team regarding the management of the rca cto with large inferior ischaemia, a mono-truncal endoluminal recanalization of the rca was performed.The lesion was pre-dilated with a 2.5x15mm euphora semi-compliant coronary balloon.Owing to under-expansion, a 3x15mm non-medtronic (mdt) non-compliant (nc) balloon was used.The optical coherence tomography (oct) showed a dissection flap over a long-calcified segment and extensive annular calcification.The dissection flap was seen at the junction between the calcification and the healthy arch of the artery.The preparation of the lesion was then optimized by a 3x15mm non-mdt cutting balloon, and a 1.5mm non-mdt rotablator.Additional pre-dilatation with a 3x15mm non-mdt nc balloon was performed.Despite this treatment, focal balloon under-expansion remained at the level of the proximal rca.A 3x38mm non-mdt drug-eluting stent was deployed with persisting focal under-expansion of the stent at the site of occlusion.Oct showed dissection flap to part of the distal stent, stent under-expansion, and coronary rupture to the proximal stent.Post-dilation with a 3x10mm non-mdt nc high pressure balloon inflation of 40 atm was useful to treat this resistant lesion.Luminal gain was observed on the control angiography without extravasation.The patient remained asymptomatic with no ekg-changes, and the haemodynamic was stable.Suboptimal outcome of this complex angioplasty was respected.Clopidogrel 75 mg, in addition to aspirin and vitamin k antagonist (vka) was added for 6 months.At the age of 14, the patient remained asymptomatic, and stress echocardiography performed 6 months after pci was negative.Systematic angiography control at 1 year after pci showed a stable lesion without in-stent restenosis.However, two false aneurysms developed at the site of intervention and required stenting with a 3.5x26mm non-mdt covered stent.The covered stent effectively treated these two false aneurysms.Owing to the covered stent implantation, prolonged dual antiplatelet therapy (dapt) was decided and vka was discontinued to limit the risk of bleeding.Systematic angiography control 6 months after the covered stent implantation was performed.The intermediate coronary stenosis of the lad remained similar.The aneurysms of the rca were completely excluded.Oct showed almost complete neointimal overlay of the covered stent, with moderate in-stent proliferation, without thrombosis or restenosis.The dapt is still ongoing after 4 years, and the 18-year-old patient has remained asymptomatic, with no physical limitation, and regular negative stress echocardiography.

Manufacturer Narrative

Additional information: annex d code.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: EUPHORA RX
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY,
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18984927
• MDR Text Key: 338660862
• Report Number: 9612164-2024-01466
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K143480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EUP2515X
• Device Catalogue Number: EUP2515X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2024
• 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; Hospitalization
• Patient Age: 13 YR
• Patient Sex: Male