MAUDE Adverse Event Report: COVIDIEN CHOCOLATE CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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

Patient Problems Reocclusion (1985); Patient Problem/Medical Problem (2688); Vascular Dissection (3160)

Event Date 03/07/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: date of publication. Sex: majority gender. Age or date of birth: average age. Journal article: a prospective, multi-center study of the chocolate balloon in femoropopliteal peripheral artery disease: the chocolate bar registry. Doi: 10. 1002/ccd. 27565 2018. Wiley periodicals, inc. Wileyonlinelibrary. Com/journal/ccd. Catheter cardiovasc interv. 2018; 91: 1144¿1148. If information is provided in the future, a supplemental report will be issued.

Event Description

This is a prospective multicenter post-approval study evaluating the use of the chocolate pta balloon in patients with femoropopliteal atherosclerotic disease. The primary endpoint was procedure success defined as a target lesion residual stenosis of 30% stenosis without a flow-limiting dissection after chocolate balloon. Secondary study endpoints included the rate of acute bailout stenting for suboptimal results; improvement in rutherford classification or ankle/toe brachial index from baseline; freedom from target lesion revascularization (tlr) at 1, 6, and 12 months; major amputation, defined as unplanned amputation at or above the ankle at 12 months; 6- and 12-month patency, defined as freedom from restenosis at the target lesion without the need of tlr. A total of 262 patients treated with a total of 290 femoropopliteal atherosclerotic lesions. The primary endpoint was achieved in 85. 1% of patients with the chocolate balloon. Bail-out stenting for a residual stenosis of >30% was used in 1. 6%. Dissections (grade a-d) were identified in 22. 5%. The 12- month patency was 64. 1% <(>&<)> 68. 3% by core lab and site report respectively. At 12 months, freedom from tlr was 78. 5%, freedom from major unplanned amputation 96%, and freedom from all-cause mortality 94%.

• Brand Name: CHOCOLATE
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8370639
• MDR Text Key: 137159284
• Report Number: 2183870-2019-00096
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/15/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 02/26/2019 Patient Sequence Number: 1