MAUDE Adverse Event Report: MEDTRONIC IRELAND IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLAS

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

Patient Problems Obstruction/Occlusion (2422); Vascular Dissection (3160); Restenosis (4576)

Event Date 01/01/2023

Event Type  Injury  

Event Description

Abstract purpose: although the optimal treatment for femoropopliteal (fp) drug-coated balloon (dcb) restenosis lesions remains debatable, the effectiveness of dcb repetition for dcb restenosis has been reported.However, the optimal dcb repetition strategy is not yet established.Thus, this study aimed to compare the clinical outcomes of high-dose dcb repetition with those of low-dose dcb repetition for fp dcb restenosis lesions.Materials and methods: this single-center, observational study used a clinical database of 677 consecutive patients undergoing fp endovascular intervention for symptomatic peripheral artery disease between (b)(6) 2018 and (b)(6) 2021.Of these patients, 89 cases treated with dcb repetition for fp dcb restenosis lesions were analyzed.The primary endpoint was recurrent restenosis (re-restenosis) and the secondary endpoints were recurrent target-lesion revascularization (tlr), re-occlusion, and major adverse limb events (male) obtained using propensity score matching.Interaction analysis was also performed to e xplore the effects of the baseline characteristics on the association between high- and low-dose dcb with restenosis risk.Results: after propensity score matching, high-dose dcb demonstrated a significantly higher freedom from re-restenosis compared with low-dose dcb repetition at 1 year ((b)(4)).In addition, freedom from re-tlr and male at 1 year was significantly higher in the high-dose dcb group ((b)(4)).Conversely, freedom rates from re-occlusion were not significantly different between the 2 groups ((b)(4)).No baseline characteristics or perioperative outcomes had any significant interaction effect on the association of high-dose dcb versus low-dose dcb with restenosis risk.Conclusion: for fp dcb restenosis lesions, high-dose dcb repetition offered more favorable outcomes than low-dose dcb repetition.

Manufacturer Narrative

Literature title effect of high-dose drug-coated balloon repetition after drug-coated balloon failure journal of endovascular therapy 1¿7 © the author(s) 2023 article reuse guidelines: sagepub.Com/journals-permissions doi: 10.1177/15266028231214167 www.Jevt.Org a2: average age a3: majority gender 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.

• Brand Name: IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLAS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18362464
• MDR Text Key: 330933369
• Report Number: 9612164-2023-06083
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P140010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• 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
• Date Manufacturer Received: 12/01/2023
• 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: 75 YR
• Patient Sex: Male