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 Embolism (1829); Reocclusion (1985); Thrombus (2101); Vascular Dissection (3160)

Event Date 12/09/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: date of publication.Journal article title: laser atherectomy and drug-coated balloons for the treatment of femoropopliteal in-stent restenosis: 2-year outcomes catheter cardiovasc interv.2020;95:439¿446 doi: 10.1002/ccd.28636.If information is provided in the future, a supplemental report will be issued.

Event Description

This article aims to examine 2-year outcomes of target lesion revascularization (tlr) and the composite outcome of tlr or restenosis through comparison of balloon angioplasty (ba) and laser atherectomy (la) versus drug-coated balloon (dcb) treatment and la using m multivariate analysis for the treatment of femoropopliteal (fp) in-stent restenosis (isr).Fp-isr lesions were crossed with a 0.035-in.Guidewire.Pre-dilation was performed before the intervention using balloons 1 mm smaller than the reference diameter.Scoring and cutting balloons and distal embolic protection devices were employed at the discretion of the operator.Apart from the scoring/cutting balloons, non-medtronic laser atherectomy was also used in all lesions for vessel preparation.Following laser atherectomy, balloon angioplasty was performed as follow-up treatment with an uncoated followed by dcbs.Of the dcb¿s used, medtronic¿s in.Pact admiral paclitaxel-eluting balloon was included.Bailout stenting was used for treatment of flow-limiting dissections or suboptimal angiographic results with residual stenosis.Lesion locations include the superficial femoral artery (sfa), popliteal artery.The following complications are reported thrombolysis, dissections, and embolizations.Lesion success in the laser and dcb group is reported as 96%.Tlr or restenosis were 45% in the la + dcb group.The article concludes that the combination of dcb + la maintains superiority over la + ba after 2 years of follow-up by decreasing the composite endpoint of tlr or restenosis.

• 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: 9888962
• MDR Text Key: 196484940
• Report Number: 9612164-2020-01382
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/27/2020

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: 03/16/2020
• Initial Date FDA Received: 03/27/2020
• 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: 70 YR