MAUDE Adverse Event Report: MEDTRONIC, INC ADVANCE; CATHETER, EMBOLECTOMY

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

Patient Problems Obstruction/Occlusion (2422); Vascular Dissection (3160); Insufficient Information (4580)

Event Date 02/21/2022

Event Type  Injury  

Manufacturer Narrative

Journal article: laser vaporization of atherothrombotic burden before drug-coated balloon application in st-segment elevation myocardial infarction: two-year outcomes of the laser-dcb trial authors: daisuke tonomura, yoshihisa shimada, yuki yamanaka, kazunori terashita, tatsuya suzuki, satoshi nishiura, masataka yoshida, takao tsuchida, hitoshi fukumoto journal: catheter cardiovascular interventions year: 2022.Reference: doi: 10.1002/ccd.30149.Age or date of birth: average age.Sex: majority gender.Date of event: 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.

Event Description

A journal article was submitted for review titled: laser vaporization of atherothrombotic burden before drug-coated balloon application in st-segment elevation myocardial infarction: two-year outcomes of the laser-dcb trial.The aim of this study was to examine whether the combination of excimer laser coronary atherectomy (elca) and drug-coated balloon (dcb) angioplasty can provide feasible clinical outcome in patients with st-segment elevation myocardial infarction (stemi) with 8-month and 2-year scheduled follow-up angiography.A total of 62 patients with stemi within 24 hours after the onset of symptoms were enrolled in this prospective, single-center, single-arm study.Lesions treated included non, mild, moderate and severely calcified lesions in the left anterior descending artery (lad), left circumflex artery (lcx) and the right coronary artery (rca).Manual aspiration thrombectomy (mt) was initially performed using either the export advance coronary aspiration catheter or a non-medtronic (mdt) device.Manual aspiration thrombectomy was repeated at least three times until there was no visible thrombotic material in the aspirate.Excimer laser coronary angioplasty (elca) was subsequently performed with a non-mdt device.The manual aspiration catheter and excimer laser catheter were successfully crossed distal to the culprit lesion in all cases.Elca-induced timi flow deterioration or perforation, distal embolization, or flow-limiting dissection was not observed in any cases.After laser atherectomy at the culprit segment, all lesions were dilated using either non-mdt cutting balloon or scoring balloon.Then, a non-mdt dcb was applied with an inflation time of at least 1 minute.The dcb was 4¿5 mm longer than the actual lesion to avoid longitudinal geographic mismatch.Angiographic dissection was observed in 20 patients and among these patients, two with type c dissection required bail-out stenting because of flow-limiting stenosis.Timi 3 flow was achieved in all patients, except in four patients with timi 2 flow.Neither procedural complications nor abrupt vessel closure was observed in any cases all patients received dapt which was continued for at least 1 month, before being reduced to just aspirin alone after the percutaneous coronary intervention (pci).All patients underwent scheduled angiographic follow-up at 8 months after the index of the procedure and 51 patients at 24 months.Binary restenosis in the treated segment was observed in three patients at 8 months and another two patients at 24 months.Target lesion revascularization (tlr) was performed in these five patients, although they were asymptomatic.Another patient underwent target vessel revascularization for the segment distal to the original culprit lesion at the 8-month follow-up.Late lumen enlargement was observed in 25 out of 60 patients at the 8-month follow-up and 19 out of 51 patients at 24-month follow-up angiography, resulting in a late lumen loss.All angiographic dissections, which were detected after the procedure, were completely healed at the follow-up.No patients in this study developed cardiac death, reinfarction, lesion thrombosis, or major bleeding with dapt.During the 24 months clinical follow-up period, five patients required non-cardiac surgery (two, colon cancer; one, gastric cancer; one, skin cancer; and one, intestinal perforation).All surgeries were successfully performed with complete discontinuation of antiplatelet drugs.

Manufacturer Narrative

Additional information: it was stated that the adverse events reported were not considered relevant to the export advance device.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: ADVANCE
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15154697
• MDR Text Key: 297140434
• Report Number: 1220452-2022-00062
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K152335
• 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: 08/08/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/22/2022
• Initial Date FDA Received: 08/03/2022
• Supplement Dates Manufacturer Received: 08/05/2022
• Supplement Dates FDA Received: 08/10/2022
• 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: 63 YR
• Patient Sex: Male