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

Catalog Number NCEUP37515X

Device Problem Burst Container or Vessel (1074)

Patient Problems Hematoma (1884); Vascular Dissection (3160); Insufficient Information (4580)

Event Date 10/14/2022

Event Type  Injury  

Event Description

A case report was submitted for review titled "noncompliant balloon shaft rupture resulting in ascending aortic dissection".The patient presented with chest pain and shortness of breath.The patient was found to have 70% in stent restenosis in the mid right coronary artery (rca).The patient was referred for vascular brachytherapy to a prior mid rca stent.Intravascular ultrasound (ivus) demonstrated under-expansion of the mid rca stent and intimal hyperplasia.The lesion was pre-dilated with a 3.5 x 12-mm non-compliant balloon to 16 atm (rated burst pressure 20 atm).A 3.5 x 12 mm non-medtronic intravascular lithotripsy balloon was delivered using a non-medtronic guide extension catheter (gec) to deliver lithotripsy to the lesion which was followed by brachytherapy.The gec was removed and the lesion was post-dilated with a 3.75 x 15-mm nc euphora non compliant balloon to 20 atm (rated burst pressure 20 atm).Upon balloon expansion, the patient reported sudden-onset severe chest pain.The balloon fully deflated.A rupture within the balloon shaft was noted along with a hydraulic dissection of the ostial rca extending into the ascending aorta.The proximal dissection was covered with a 4.0 x 15 mm covered stent.Angiography confirmed that there was an adequate seal of the dissection.Post-lithotripsy, post-brachytherapy and post-dilation intravascular ultrasound demonstrated further expansion of the stent area.Follow-up computed tomography angiography demonstrated a thin rim of intramural hematoma along the ascending aorta with no separate dissection flap noted.Repeat computed tomography angiography the next day demonstrated a decreased size of the hematoma.The patient was discharged several days later in a stable condition.It was stated that the patient's severe chest pain immediately upon post-dilation of the rca lesion correlated temporally with the balloon shaft rupture and the appearance of the aortic dissection and hematoma which suggested that it was the rupture of the nc euphora balloon shaft that resulted in the proximal rca and aortic root dissection.

Manufacturer Narrative

Title: noncompliant balloon shaft rupture resulting in ascending aortic dissection.Authors: ryan kabir, gaby weissman, toby rogers, hayder hashim, lowell f.Satler, ron waksman, itsik ben-dor journal name: jacc: cardiovascular interventions year: 2023 reference: doi.Org/10.1016/j.Jcin.2022.10.031.B3: date of publication.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

Additional information: annex d code.Correction: annex e code.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 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: 16987119
• MDR Text Key: 315829542
• Report Number: 9612164-2023-02160
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/04/2023

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 Catalogue Number: NCEUP37515X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2023
• Initial Date FDA Received: 05/23/2023
• Supplement Dates Manufacturer Received: 06/29/2023
• Supplement Dates FDA Received: 07/05/2023
• 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): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male