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 Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Renal Failure (2041); Hemorrhagic Stroke (4417); Restenosis (4576); Insufficient Information (4580)

Event Date 12/15/2020

Event Type  Injury  

Manufacturer Narrative

Journal title: comparison of long term outcomes after endovascular treatment versus bypass surgery in chronic limb threatening ischaemia patients with long femoropopliteal lesions eur j vasc endovasc surg (2021) 61, 258e269 european society for vascular surgery.Published by elsevier b.V.All rights reserved.Https://doi.Org/10.1016/j.Ejvs.2020.11.009.Age or date of birth: average age.Sex: majority gender.Date of event: date available online.If information is provided in the future, a supplemental report will be issued.

Event Description

Objective: there are currently two treatments available for patients with chronic limb threatening ischaemia (clti): open surgical bypass (osb) and percutaneous transluminal angioplasty with/without stenting (pta/s).The aim of this study was to compare short and long term outcomes between pta/s and osb in clti patients with long (glass grade iii and iv) femoropopliteal disease.Methods: thiswas a two centre retrospective study including all consecutive patients with clti undergoing first time lower extremity intervention at two distinct vascular surgical centres.Between 1 january 2012 and 1 january 2018, 1 545 clti consecutive limbs were treated for femoropopliteal glass grade iii and iv lesions at two vascular surgical centres.Using covariables from baseline and angiographic characteristics, a propensity score was calculated for each limb.Thus, comparable patient cohorts (235 in pta/s and 235 in osb group) were identified for further analysis.The primary outcomes were freedom from re-intervention in the treated extremity and major amputation.Secondary outcomes were all hospital complications among the two patient groups.Results: total overall complication rates were significantly higher in the osb group (20.42% vs.5.96%, p <(><<)>.001), especially wound infection/seroma rate that required prolonged hospitalisation and further treatment (7.65% vs.0%, p <(><<)>.001).After the median follow up of 61 months, re-intervention rates were significantly higher in the pta/s group (log rank test, 44.68% vs.29.79%, p ¼.002), but there was no significant difference in terms of major amputation rates between the two group of patients (log rank test, pta/s 27.23% vs.Osb 22.13%, p ¼.17).Conclusion: bypass surgery seems to be superior to pta/s for glass grade iii and iv femoropopliteal lesions in patients with clti in terms of long term re-intervention rates, but with considerably higher rates of postoperative complications.A larger cohort of patients in currently ongoing randomised trials, as well as prospective cohort studies are necessary to confirm these findings.

• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 11540091
• MDR Text Key: 241402958
• Report Number: 9612164-2021-01075
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• 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: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• 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
• Date Manufacturer Received: 03/15/2021
• 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: 68 YR