• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COVIDIEN CHOCOLATE CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
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%.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCHOCOLATE
Type of DeviceCATHETER, 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 Key8370639
MDR Text Key137159284
Report Number2183870-2019-00096
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130414
Number of Events Reported1
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 Received02/26/2019
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 Received02/15/2019
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
-
-