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 Vascular Dissection (3160); Restenosis (4576)

Event Date 09/28/2022

Event Type  Injury  

Event Description

Medtronic received a journal article title 'two-year clinical outcomes and predictors of restenosis following the use of polymer-coated paclitaxel-eluting stents or drug-coated balloons in patients with femoropopliteal artery disease'.The study reports the primary patency (pp), freedom from clinically driven target lesion revascularization (cd-tlr), and predictive factors of restenosis after pc-pes and dcb for lead treatment in patients with femoropopliteal lesions within 2 years of the procedures.Additionally, the study assessed the similarity of the 2-year outcomes and predictive factors of restenosis with of the 1-year outcomes and predictive factors using clinical registry data.151 patients were enrolled in this study.Overall, 65 (43.0%) cases were treated with pc-pes and 86 (57.0%) cases were treated with dcb.In the dcb group, 77 patients (89.5%) were treated by in.Pact admiral¿ and nine patients (10.5%) were treated by non-medtronic balloons.There were 18 post procedural dissections in the dcb group.During the follow-up, 39 cases had pp loss (pc-pes group, 12 cases; dcb group, 27 cases), and 17 cases had cd-tlr (pc-pes group, 8 cases; dcb group, 9 cases).In the patients with pp loss treated by dcb, 33% patients underwent tlr; while, 44% patients were asymptomatic and 22% patients did not undergo tlr because of patients¿ wish or physicians¿ discretion.

Manufacturer Narrative

Title: two-year clinical outcomes and predictors of restenosis following the use of polymer-coated paclitaxel-eluting stents or drug-coated balloons in patients with femoropopliteal artery disease authors: naoki yoshioka, takahiro tokuda, akio koyama, takehiro yamada, kiyotaka shimamura, ryusuke nishikawa, yasuhiro morita, itsuro morishima journal: heart and vessels issues: (2023) 38:429¿437.Reference: doi://10.1007/s00380-022-02182-0.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.

• 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: 17143125
• MDR Text Key: 317331565
• Report Number: 9612164-2023-02656
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/16/2023

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/01/2023
• Initial Date FDA Received: 06/16/2023
• 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