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

MAUDE Adverse Event Report: COVIDIEN EVERCROSS 035 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 EVERCROSS 035 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number AB35W09060080
Device Problem Burst Container or Vessel (1074)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 08/15/2017
Event Type  Injury  
Manufacturer Narrative
Additional information received: the lesion length was approximately 4cm long, >90% stenosis and heavily calcified. The artery had an 8. 3mm lumen on angiography. The procedure was bilateral stenting of the both iliac arteries which was successfully completed using a protege 9 x 60 mm stent. The procedure used a 6fr 11cm non-medtronic sheath and a amplatz extra stiff guidewire. A non-medtronic inflation device with half saline/half contrast was used. Each balloon burst occurred somewhere between rated and burst pressure. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The physician performed a bilateral stenting procedure of both right and left common iliac arteries with unknown stents using ¿kissing¿ technique. It was reported that post stent deployment, the need for further angioplasty was identified in the right mid common iliac artery. The lesion was calcified and the artery had little tortuosity. An evercross 9mmx40mm pta balloon was used to perform the angioplasty procedure. The device was removed from its packaging and inspected with no issues noted. The device was prepped as per the ifu. No embolic protection was used. It was reported that this balloon burst on inflation without any incident. A second evercross 9mmx60mm pta balloon was selected for use. It was reported that a circumferential/ radial burst occurred during inflation for this balloon. It was noted that an inch of the tip was missing. This was confirmed by further imaging which demonstrated the broken piece still in situ. The physician had trouble in removing the fragments of the balloon from the artery. This broken tip couldn't be retrieved via snare. A surgical intervention under general anesthesia was required to remove fragments. The surgery was reported to be successful in removing the fragments. No apparent ill effects to the patient were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEVERCROSS 035
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 Key6881802
MDR Text Key100532347
Report Number2183870-2017-00413
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K082579
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/26/2019
Device Catalogue NumberAB35W09060080
Device Lot NumberA316579
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/17/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/26/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/21/2017 Patient Sequence Number: 1
-
-