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 10/06/2022

Event Type  Injury  

Event Description

Medtronic received a journal article titled 'clinical outcome of drug-coated balloons in patients with femoropopliteal chronic total occlusive lesions: results from the multicenter eagle study'.The eagle (clinical result of endovascular treatment with drug-coated balloon for femoropopliteal chronic total occlusion) study is a multicentre, retrospective analysis from the prospectively maintained database.Between april 2017 and february 2021, 3635 consecutive symptomatic pad patients with fp lesions received evt, and 1457 lesions had cto segments.Of these, 359 lesions (318 patients) were treated with dcb and enrolled in this study.Patients with non-atherosclerotic disease including vasculitis or systemic inflammatory disease, life expectancy of less than 1 year, advanced malignancy, acute limb ischemia, and congenital anatomical abnormalities such as persistent sciatic artery, or aneurysmal lesions were excluded.Te selection of dcb (high dose or low dose) was decided based on each operators¿ decision.After the insertion of a guiding sheath from the ipsilateral or contralateral femoral artery, 0.014-, 0.018-, or 0.035-in.Guidewires were used with a back-up support catheter.A bi-directional approach was conducted as needed.The type of pre-dilation balloon used (semi-compliant, noncompliant, cutting, or scoring balloon) depended on the operator.Dcb was used after confirming as much as possible that the residual stenosis was less than grade d.The evaluation of a pressure gradient was performed as required, and pressure gradients <(><<)>10mmhg were defined as significant stenosis.After successful lesion preparation, the target lesion was fully covered by the dcb (geographic mismatches were carefully avoided).If >50% residual stenosis or the national heart, lung and blood institute (nhlbi) grade d or higher dissection was observed after using dcb, bailout stenting was considered (the necessity of stent use was finally judged by each operator).High-dose dcb (3.5¿g/mm2 ) was in.Pact admiral dcb (medtronic vascular, santa clara, ca, usa), and low-dose dcb (2.0¿g/mm2 ) was non-medtronic dcb.Procedural success was defined as <(><<)>50% residual stenosis without angiographic flow-limiting dissection.32 patient had stent i mplantation.204 dissections after dcb were reported.Major amputation reported as 4 (1.3%).All-cause mortality reported as 45 (14.2%).During the study period, restenosis was detected in 93 cases.The 12-month primary patency was 79.8%, whereas the corresponding rates of freedom from cd-tlr and re-occlusion were 86.4% and 88.5%, respectively.

Manufacturer Narrative

Title: clinical outcome of drug-coated balloons in patients with femoropopliteal chronic total occlusive lesions: results from the m ulticenter eagle study authors: naoki hayakawa, mitsuyoshi takahara, tatsuya nakama, kazunori horie, keisuke takanashi1 , teruaki kanagami, shinya ichihara, masataka arakawa, kazuki tobita, shinsuke mori, yo iwata, kenji suzuki and journal: cvir endovascular year: 2022 issue: 5:51 reference: doi.Org/10.1186/s42155-022-00329-8.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: 16584328
• MDR Text Key: 311708871
• Report Number: 9612164-2023-01206
• 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: Physician
• Type of Report: Initial
• Report Date: 03/21/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2023
• Initial Date FDA Received: 03/21/2023
• 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: 76 YR
• Patient Sex: Male