MAUDE Adverse Event Report: COVIDIEN CHOCOLATE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

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

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

Event Date 02/15/2024

Event Type  Injury  

Manufacturer Narrative

Ref:doi.Org/10.1177/15266028241231036.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.

Event Description

Medtronic received a literature article reporting a retrospective analysis of prospectively collected data from the civilian (clinical investigation of different lesion preparation modality followed by dcb in femoropopliteal artery occlusion disease) registry.Between march 2021 and november 2022, 3 pre-dilation techniques used prior to the dcb angioplasty were included.During the study period, 435 limbs from 429 patients were included in this study.Of these limbs, 166 underwent pre-dilation with clp (chocolate balloon pre-dilatation) , 93 with sp (sequential enlarging angioplasty pre-dilatation (sequential balloon pre-dilation [sp])) , and 176 with cp (conventional balloon pre-dilatation).There was no significant difference in the bailout stenting rate between the clp group and the sp group (18.1% vs 22.6%), or between the sp group and the cp group.The percentage of severe dissection in the clp group was 18.1% (30/166).During the 6-month follow-up visit, 12 patients (7.2%) in the clp group experienced maes.Three patients (1.8%) in the clp group had cd-tlr within 6 months.Two patients in each of 3 groups had major amputation.

• Brand Name: CHOCOLATE
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18977914
• MDR Text Key: 338588809
• Report Number: 2183870-2024-00104
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K130414
• 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: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• 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: 02/27/2024
• 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