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

Model Number SLC1512X

Device Problems Burst Container or Vessel (1074); Material Deformation (2976)

Patient Problem Obstruction/Occlusion (2422)

Event Date 02/06/2024

Event Type  Injury  

Event Description

An attempt was made to use two solarice coronary balloon catheters to treat a lesion.There was 90% in-stent restenosis (isr) to the ostial first diagonal (d1) artery, and 60% moderate diffuse isr in the left anterior descending (lad) artery stent.Plain old balloon angioplasty (poba) was performed to the d1.It was reported that the first balloon (lot#225059580) burst during inflation to 18 atm and the second balloon (lot#226915212) burst during inflation to 9 atm.It was also reported that one of the balloons broke while attempting to remove the balloon.A stent had to be implanted in the lad to trap the ruptured balloon against the proximal lad wall.Percutaneous coronary intervention (pci) was done with a 3.0x26mm resolute onyx stent to the proximal/mid lad, which was post dilated with a 3.0mm nc high pressure balloon.Poba was performed in the ostial d1 with a 2.0 balloon but could not be re-wired after the lad stenting.The d1 occluded.The patient was stable without any chest pain, therefore there was medical treatment for the d1.No further patient injury reported.

Manufacturer Narrative

Please note that this device (solarice) is not marketed in the united states; however, the device is deemed the same as the united states marketed device (euphora).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.

Manufacturer Narrative

Product analysis summary: a kink was evident on the hypotube.The device returned with balloon folds intact.No evidence of necking on the proximal balloon bond / distal inflation lumen.No deformation was evident to the tip.The balloon passed negative prep.The balloon was inflated to 9 atms and maintained pressure.The specification for a low-profile balloon 1.50mmx12mm is 6atms, with a rated burst pressure of 12 atms.No other deformation evident to the remainder of the device.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: 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: 18694054
• MDR Text Key: 335192733
• Report Number: 9612164-2024-00749
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K143480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SLC1512X
• Device Catalogue Number: SLC1512X
• Device Lot Number: 226915212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2023
• 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): Other; Required Intervention