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

Model Number UNK-CV-GWY-INPACAD

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

Patient Problems Ischemia (1942); Perforation (2001); Vascular Dissection (3160); Embolism/Embolus (4438)

Event Date 01/01/2023

Event Type  Injury  

Event Description

Abstract purpose: this study examines the use and impact of directional atherectomy with antirestenotic therapy (daart) versus angioplasty plus supera stent implantation on the outcomes during endovascular treatment of popliteal lesions in clinical practice.Methods: overall 143 consecutive patients (mean age 75.0±12.2 years, 72% male), with isolated atherosclerotic disease of the popliteal artery who underwent endovascular treatment using daart therapy or percutaneous transluminal angioplasty (pta)/supera stenting of the popliteal artery between (b)(6) 2016 and (b)(6) 2021 were identified from a retrospectively database.Patient and plaque characteristics were collected.A propensity-score matched, case-control analysis was conducted to balance covariates between the group of patients who underwent daart and the one treated by pta/supera stenting.Results: a total of 51 patients (35.7%) showed severe claudication and 92 (64.3%) critical limb ischemia.There was a trend toward longer treated lesions (90.4±81 vs 72.5±5.3 mm, p=0.089) and more chronic total occlusions (60.5% vs 46.8%, p=0.058) in the pta/supera stenting group, although not reaching statistically sign ificance.Moderate-to-severe calcification was present in most lesions treated (75.8% of daart group, 80.2% of pta/supera stenting group, and 78.3% of total cohort).Among the 53 case-matched pairs of patients treated with daart or pta/ supera stenting, there were no significant differences in short-term outcomes, including rate of technical success (96.2% vs 98.1%, p=0.232), procedural success (88.7% vs 90.1%, p=0.251), distal embolization (1.9% vs 1.9%, p=0.178), dissection (5.7% vs 1.9%, p=0.268), perforation (3.8% vs 5.6%, p=0.163), hospital discharge (1.2±0.1 vs 1.0±0.1, p=0.325), 30 day minor (28.3% vs 32.1%, p=0.264) or major amputation rates (7.5% vs 3.8%, p=0.107), and 30 day mortality (1.9% vs 1.9%, p=0.173).At 1 year, there was no difference in primary patency (73.6% vs 77.4%, p=0.233), primary assisted patency (81.3% vs 84.9%, p=0.167), secondary patency (86.8% vs 92.5%, p=0.094), ipsilateral minor (35.8% vs 39.6%, p=0.472) or major amputation (9.4% vs 7.5%, p=0.186), ankle brachial index improvement (0.32±0.12 vs 0.37±0.37, p=0.401), or mortality (5.7% vs 5.7%, p=0.121) rate between patients who underwent daart or pta/supera stenting for popliteal lesions.Conclusion: twelve-month results following daart technique or pta/supera stenting of atherosclerotic lesions of the popliteal artery are not different, regardless of patient and plaque characteristics.

Manufacturer Narrative

Article title : directional atherectomy with antirestenotic therapy versus pta/supera stenting for popliteal artery lesions: a prope nsity-matched analysis journal of endovascular therapy 1¿11 © the author(s) 2023 article reuse guidelines: sagepub.Com/journals-permissions doi: 10.1177/15 266028231199923 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.

Manufacturer Narrative

Correction to pma number section.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 ANGIOPLASTY CATHETER
• 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: 18562066
• MDR Text Key: 333443217
• Report Number: 9612164-2024-00361
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P140010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-CV-GWY-INPACAD
• Device Catalogue Number: UNK-CV-GWY-INPACAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2024
• 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