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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN EVERCROSS 035; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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COVIDIEN EVERCROSS 035; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number AB35W09040080
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Perforation (2001)
Event Date 05/29/2018
Event Type  Death  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient in this incident had a total right proximal to mid iliac occlusion that was approached retrograde on the right side.The vessel was pre-dilated.The target lesion was a cto (chronic total occlusion-100%) with severe calcification.The vessel was moderately tortuous.A viance catheter was initially used to try and cross the lesion but went sub-intimal and potentially outside the vessel in this attempt below the occlusion.A guide wire and re-entry catheter were used successfully to eventually navigate past the lesion and re-enter the iliac.Treatment to the proximal right iliac then was originally approached with the thought in mind of using a protégé gps on the ostial and proximal iliac with the goal of not compromising or jailing the internal iliac.A 10x80 protégé gps was deployed successfully.An everflex 8x80 was used to treat a stenosis on the left iliac successfully as well.It was then noted the patient¿s bladder looked compressed, a typical sign of an internal bleeding situation.A non-mdt covered stent was placed distal to the 10x 80 protégé in the right illiac where the bleed appeared to be and this seemed to resolve the issue.Upon further examination of the proximal right protégé gps stent, there was some angiographic haziness in the stent and the decision was made to post dilate the stent.The post dilatation was done with a 9x40 evercross.After post dilatation, the angiographic image showed a massive perforation at the stent level.A 10x38 non-mdt stent was placed in the 10mm protégé stent and additional 9x 38 or 9x58 non -mdt stent were deployed distal to the 10x38 stent.Angiographically, the perforation seemed to be resolved.There was no difficulty with deploying the protégé stents or removing the delivery systems.The patient left the cath lab and was put into icu.Later in i cu the patient had to be intubated and then had to go to the or for surgery.The patient later died the next day.This patient had many additional issues that were not elaborated.No cause of death nor autopsy report is available.
 
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Brand Name
EVERCROSS 035
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 Key7640849
MDR Text Key112413182
Report Number2183870-2018-00356
Device Sequence Number1
Product Code LIT
UDI-Device Identifier00821684062159
UDI-Public00821684062159
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082579
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 06/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/12/2021
Device Catalogue NumberAB35W09040080
Device Lot NumberA597028
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/30/2018
Initial Date FDA Received06/27/2018
Date Device Manufactured02/13/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death;
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