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 Occlusion (1984); Injury (2348)

Event Date 06/14/2019

Event Type  Injury  

Manufacturer Narrative

Journal title: amputation-free survival in patients with critical limb ischemia treated with paclitaxel-eluting stents and paclitaxel-coated balloons.Authors: john phair, matthew carnevale, evan c.Lipsitz, saadat shariff, larry scher and karen garg.Journal: annals of vascular surgery.Year: 2019 ref: doi: https://doi.Org/10.1016/j.Avsg.2019.05.013.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported in the literature article, amputation-free survival in patients with critical limb ischemia treated with paclitaxel-eluting stents and paclitaxel-coated balloons, that a study was carried out to evaluate the performance of paclitaxel-eluting stents (pess) and paclitaxel-coated balloons (pcbs) on amputation free survival in patients with critical limb ischemia (cli) over a 4-year period.In.Pact dcb products were used in the study along with other non-medtronic devices.Patients who underwent concurrent tibial vessel balloon angioplasty and patients who underwent tibial atherectomy at the time of their surgery were also analysed.Patients with calcified vessels that were treated with dcbs were pre-treated with atherectomy.There was no difference in wound healing for those treated with concurrent tibial intervention.The primary endpoint of the study was amputation-free survival at 12 months.The secondary endpoints included wound healing, freedom from target lesion revascularisation and patency of target vessels at 12 months.A retrospective, single centre study of a total of 88 patients was carried out.Drug-eluting stent (des) was used as the sole drug technology in 56 patients and drug-coated balloon (dcb) was the sole drug technology in 32 patients.27 of the dcb patients were tr eated with a non-medtronic (bard) device.All patients with rutherford class 5 and 6 who underwent femoropopliteal intervention with in.Pact dcb devices and non-medtronic devices over 4 years were compiled and analysed.Patients with calcified vessels that were treated with dcbs were pretreated with atherectomy.After 12 months, amputation-free survival in all patients was 82.17%.In the dcb p atients, amputation-free survival after 12 months was 71.1%, wound healing rates was 59.4%, freedom from target lesion revascularisation was 85.7% and target lesion patency was 58.1%.Patients that required reintervention were treated within one month of ultrasound findings suggesting restenosis.One patient that was initially treated with dcbs underwent des placement for restenosis.Five patients that received dess ultimately required open bypass for failed endovascular therapy.

• 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: 9642360
• MDR Text Key: 176809929
• Report Number: 9612164-2020-00466
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/29/2020

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: 01/15/2020
• Initial Date FDA Received: 01/29/2020
• 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: 71 YR