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

Catalog Number NCSLC4020X

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

Patient Problem Vascular Dissection (3160)

Event Date 04/26/2021

Event Type  Injury  

Manufacturer Narrative

Title: stent underexpansion due to heavy calcification in a patient with recent acute coronary syndrome successfully treated with lithotripsy authors: rafal januszek, stanislaw bartus journal: clinical vignette issue: 7-8 ref: doi: 10.33963/kp.15970.Date of publication.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article titled - stent underexpansion due to heavy calcification in a patient with recent acute coronary syndrome successfully treated with lithotripsy - was submitted for review.This article is a case study of a patient who presented to hospital with acute coronary syndrome.Coronary angiography (ca) of the right coronary artery (rca) revealed an edge in-stent restenosis of a previously implanted stent, with heavy calcifications in the arterial wall.The lesion was crossed with a non-mdt guidewire to the distal segment of the rca.Due to the unsuccessful attempts of pre-dilation with a non-mdt balloon the buddy wire technique was used.Then sequential inflations were done with three non-mdt semi-compliant balloons.The residual stenosis remained at around 70%¿80%.A high pressure non-mdt balloon was then inflated up to 40 atm with no success.Despite the use of the buddy wire technique and a non-mdt guide extension catheter, a non-mdt drug eluting stent (des) did not reach the distal segment of the artery.The patient was qualified for lithotripsy.Lithotripsy with a non-mdt device and a catheter balloon with 4¿6 atm was performed.This enabled the final optimization of stent expansion using a 4.0 × 20 mm medtronic nc solarice balloon catheter with 22 atm.Dissection of the coronary artery wall behind the stent was found and required a non-mdt stent to be implanted.Stent optimization was performed using a 4.0 × 20 mm nc solarice balloon catheter with 8-20 atm.Control ca and optical coherence tomography (oct) showed an acceptable effect of the pci within the rca.Please note that this device (nc solarice) is not marketed in the united states; however, the device is deemed the same as the united states marketed device (nc euphora).

Manufacturer Narrative

Additional information: procedural images in the article provided the basis of analysis.The images provided confirm the reported dissection.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: NC SOLARICE 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: 14141036
• MDR Text Key: 289500662
• Report Number: 9612164-2022-01500
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K141090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: NCSLC4020X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2022
• Initial Date FDA Received: 04/19/2022
• Supplement Dates Manufacturer Received: 06/08/2022
• Supplement Dates FDA Received: 06/09/2022
• 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: 84 YR
• Patient Sex: Male