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

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

Patient Problems Intimal Dissection (1333); Reocclusion (1985); Thrombosis (2100)

Event Date 10/18/2019

Event Type  Injury  

Manufacturer Narrative

Journal title: midterm outcomes of drug-coated balloon angioplasty in femoropopliteal lesions in a daily practice cohort journal: annals of vascular surgery year: 2019 ref: doi: 10.1016/j.Avsg.2019.09.032.Average age.Majority gender.Date of publication death was reported as a clinical outcome of this study, however there is no information to suggest the device has caused or contributed to a death.If information is provided in the future, a supplemental report will be issued.

Event Description

A study was performed to evaluate the midterm outcomes of dcb angioplasty in femoropopliteal artery disease and to identify risk fac tors for restenosis.All patients were treated with the in.Pact admiral drug-coated balloon after predilatation with poba a total of 109 patients (113 legs), (51 male, 59 female, mean age, 72 ± 10) were treated with dcb angioplasty between january 2015 and september 2016.Provisional stents were placed if indicated.Data were retrospectively collected from digital patient records.No exclusion criteria were applied.The primary end point was primary patency.Secondary end points were primary assisted patency, secondary patency, clinically driven target lesion revascularization (cd-tlr) and major adverse events.All end points were calculated with the kaplan-meier analysis.The univariable and multivariable cox regression analyses were performed to identify risk factors for restenosis.All patients received a standardized follow-up at 8 weeks, 6 months, 1 year, and annually thereafter.The follow-up included clinical examination and ankle brachial index (abi) with or without walking test.In the case of recurrent symptoms or a significant decrease in abi, a duplex ultrasonography, magnetic resonance angiography, or computed tomography angiography was performed.After the intervention, all patients stayed at least one night in hospital and received low molecular weight heparin subcutaneously at a prophylactic dosage for the duration of hospital stay.In addition, all patients received acetylsalicylic acid (80 mg) in combination with clopidogrel (75 mg) for 6 months.After 6 months, only clopidogrel was continued.All patients were prescribed a statin.Patients with a preoperative anticoagulant regime instead of dual antiplatelet therapy, for example, a vitamin k antagonist or a direct anticoagulant, continued similarly after the endovascular intervention.All patients were prescribed a statin.One patient experienced thrombosis one day after intervention.De novo lesions were treated in 74% of the interventions.Total occlusions were treated in 38%, and provisional stents were implanted in 30% of the patients.Patients suffered from cli in 52% of the cases (rutherford score >- 4).The rate of critical limb ischemia was 52% and total occlusions were treated in 38%.The mean follow-up was 24 ± 13 months.Primary patency rates were 87%, 79%, and 61% at 1, 2, and 3 years, respectively.Primary assisted patency rates were 95%; 89%, and 79%; secondary patency rates were 99%, 97%, and 91%; and cd-tlr rates were 6.9%, 14.3%, and 20.6% at 1, 2, and 3 years, respectively.Overall mortality and major target limb amputation rates were 18% and 5% at 3 years.Multivariable analysis demonstrated that only trans-atlantic inter-society consensus (tasc) d lesions were associated with restenosis (p ¼ 0.008).No device- or procedure-related deaths were reported, and none of the reported death causes were related to one of the feared side effects of paclitaxel,.

• 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 ; IE
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 9738915
• MDR Text Key: 189153231
• Report Number: 9612164-2020-00841
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P140010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/21/2020

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: 02/16/2020
• Initial Date FDA Received: 02/21/2020
• 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: 72 YR