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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 AB35W10040080
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Perforation of Vessels (2135); Blood Loss (2597)
Event Date 09/25/2017
Event Type  Death  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The physician was attempting to use a protégé gps self-expanding stent to treat a moderately calcified lesion with 85% stenosis located in the right proximal mid distal common iliac artery. There was no degree of tortuosity and there were no abnormalities reported in relation to patient anatomy. The lesion was predilated using an 8 x 60 evercross pta balloon, prior to deployment of the stent. There was no damage noted to the packaging of the 8x60 balloon and there were not any issues noted when removing the device from the hoop/tray. The device was prepped per the ifu with no issues noted. A competitor¿s 7fr sheath and a 0. 035 guidewire was used during this procedure and embolic protection was not used. The device was inflated using a competitor¿s inflation device using inflation fluid. The device did not pass through a previously deployed stent. No resistance was encountered when advancing the device. Excessive force was used during delivery. After pre-dilation, the protégé gps stent was successfully deployed in the target area. Embolic protection was not used. A 10x40 evercross pta balloon was used to post dilate the lesion after the stent was deployed. The device was prepped per the ifu with no issues no resistance was encountered when advancing the device. Excessive force was used during delivery. The device was inflated using a competitor¿s inflation device using the inflation fluid. The physician made multiple inflations with this balloon inside the stent and distal to the stent in the external iliac artery. It was reported that during this procedure, the patient started to get short of breath and compressions were started. The physician had perforated the right iliac artery with the 10x40 evercross pta balloon. After the artery was perforated, two surgeons were called in and inflated the 8x60 evercross balloon to occlude the bloodflow and prevent bleeding. The patient was taken from the outpatient lab and brought to the hospital for surgery. It was reported that the patient expired due to the complications. The physician stated that oversized balloon perforated the vessel, and that there is no allegation of product malfunction against the devices. The physician reported that the devices worked fine.
 
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Brand NameEVERCROSS 035
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
COVIDIEN
4600n nathan lane
plymouth MN 55442
Manufacturer (Section G)
COVIDIEN
4600n nathan lane
plymouth MN 55442
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key6978417
MDR Text Key90285485
Report Number2183870-2017-00464
Device Sequence Number1
Product Code LIT
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
Remedial Action Notification
Type of Report Initial
Report Date 10/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberAB35W10040080
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 Received09/25/2017
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

Patient Treatment Data
Date Received: 10/25/2017 Patient Sequence Number: 1
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