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 Reocclusion (1985); Patient Problem/Medical Problem (2688); Vascular Dissection (3160)

Event Date 11/16/2018

Event Type  Injury  

Manufacturer Narrative

Average age.Sex: majority gender.Date of event: date of publication, article title feasibility and mid-term outcomes of drug-coated balloon angioplasty between intermittent claudication and critical limb ischemia in patients with femoropopliteal disease chien-an hsieh et al.Peripheral arterial occlusive disease acta cardiol sin 2019;35:308_319 308 doi: 10.6515/acs.201905_35(3).20181116a.If information is provided in the future, a supplemental report will be issued.

Event Description

This article aims to investigate the clinical characteristics and outcomes of dcbs in symptomatic femoropopliteal disease between patients with intermittent claudication (ic) and cli and is based on a retrospective analysis.It reports on 151 patients who underwent dcb angioplasty for symptomatic femoropopliteal disease.The angiographic inclusion criteria were de novo, restenotic and in-stent stenotic or occlusive femoropopliteal lesions.Concomitant interventions for iliac or tibial lesions were allowed in the study patients.Clinical characteristics and outcomes regarding binary restenosis, amputation-free survival (afs), and major adverse limb events (males) between groups were compared.Of the drug-coated balloons used, medtronic¿s in.Pact admiral device was included.Bare metal stents (bmss) were implanted in cases of suboptimal angiographic results or flow-limiting dissections after treatment with the dcbs.Over 60-month follow-up period 33 patients are reported to have died (4 ic and 29 cli).3 patients¿ (1 ic and 2 cli) underwent major amputations.66 treated limbs are reported to have developed re-stenosis after dcb treatment.Of these patient¿s 45 underwent repeat endovascular therapy (evt) due to symptom recurrence.The author concluded that despite advanced limb ischemia and comorbidities, the mid-term outcomes in surviving cli patients were similar to those in the ic patients after treatment with dcbs for femoropopliteal disease.

• 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
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8925620
• MDR Text Key: 155355175
• Report Number: 9612164-2019-03548
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2019
• Initial Date FDA Received: 08/23/2019
• 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: 71 YR