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

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

Patient Problems Perforation (2001); Stenosis (2263); Vascular Dissection (3160)

Event Date 05/04/2020

Event Type  Injury  

Event Description

Medtronic received a literature article titled 'two-year outcomes of orbital atherectomy combined with drug-coated balloon angioplasty for treatment of heavily calcified femoropopliteal lesions'.63 patients were treated with dcb ( drug coated balloon) and 50 patients were treated with oa+dcb (orbital atherectomy + drug coated balloon) all the interventions were performed by 3 operators using a treatment strategy for oa+dcb that was similar to a previous study.21 lesions were crossed with a 0.018- or 0.035- inch guidewire, followed by exchange using a support catheter or balloon for a viperwire and the diamondback 360 peripheral oa system (non-medtronic).Oa runs were performed with low, medium, or high speed, based on the lesion characteristics and vessel size, in order to optimize the angiographic outcome.In general, a crown size of 1.5 mm was used for popliteal lesions and a 2.0-mm crown for femorallesions.The number of passes performed and the use of distal embolic protection were at the discretion of the operator.When embolic protection was used, an emboshield nav6 (non-medtronic) was utilized.After oa, dcb angioplasty was performed using the in.Pact admiral balloon (medtronic) inflated at 8 atmospheres for 3 minutes, with the dcb sized 1:1 to the reference vessel.In cases wherea suboptimal angiographic result was achieved or a complication (eg, flow-limiting dissection) occurred, adjunctive therapy including bailout stenting was performed at the operator¿s discretion.The general approach in these cases was to stent only the affected area rather than the entire lesion.The stent type used in such cases was the interwoven nitinol stent (non-medtronic).Procedural success was similar at 70% in both groups, and there were no differences in the angiographic complications.Non¿flow-limiting dissection, flow limiting dissection and 1 perforation (in the oa+dcb group) were reported.Two year follow up reported freedom from tlr 76% in the oa+dcb group and vs 56% in the dcb only group, three amputations occurred among patients treated with dcb alone.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLAS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18942357
• MDR Text Key: 338186802
• Report Number: 9612164-2024-01344
• 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: Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2024
• 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