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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number G35349
Device Problems Positioning Failure (1158); Dent in Material (2526); Difficult to Advance (2920)
Patient Problems Rupture (2208); Blood Loss (2597)
Event Date 08/27/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). Name and address for importer site: (b)(4). Investigation is still in progress.

 
Event Description

Description according to initial reporter: "after taking aortogram just proximal to the aortic bifurcation to determine the status of both right and left common iliac and right and left external iliacs physician placed a les. 035 260cm guide wire through a kmp catheter into the aortic arch; a pigtail catheter placed over a glide wire was to take angiograms intra-op through a 6fr sheath on right side common femoral. Physician placed an 16fr and then 18fr hydrophilic dilator over the les wire guide to dilate the left ext and common iliac. We then tried to advance the alpha 34x113 device but could not get the device past mid left common iliac; physician took device out and used 18fr x 33cm dry seal to hold the abbott pro-glide arteriotomy. He then decided to balloon the left and right common iliac with 8mm x 40mm bilateral kissing balloons; we again tried to advance the alpha device but felt it was catching in the lower left external iliac; a 7mm x 120mm evercross was then used to balloon the entire length of the left external illiac and again we tried to advance the alpha device but it would not pass through the left common iliac artery. An 8mm x 80mm balloon was also used to open up the left external iliac artery; the decision was made to introduce a gore viabahn self expanding covered stent 8mm x 7. 5mm and deploy this stent in the left external iliac; this was done successfully and a 9mm x 40mm balloon was the 8mm x 7. 5cm viabahn; after ballooning the 34 x 113 alpha device was then placed over the les wire guide and advanced to the mid common iliac artery where it was met with resistance; a gore 22fr x 33 dry seal sheath was also introduced but could not be advanced through the left ext iliac. Throughout every advance of the alpha device the device sheath seemed to buckle at the very distal edge of the stent-graft and a small kink was observed in the device sheath after taking the device out multiple times. The final advancement of the alpha 34 x 113 occurred just after the viabahn (endo conduit) was placed; physician tried to advance the device and under fluoroscopy could not get device past the common iliac; as we pulled device back under fluoroscopy physician discovered the the viabahn had been dragged down with the device; at this point the patients pressure dropped and immediately physician pulled alpha device out of the patient; the device was observed to have the entire left external iliac artery with viabahn stuck to the sheath of the device; a amplatzer. 035 x 260cm wire guide was in the right side into the descending aorta; physician placed a 18fr x 33cm dry seal sheath over the amplatzer wire and immeditately place a coda 32mm balloon over the wire through the 18fr sheath; balloon was placed in infrarenal aorta just proximal to bifurcation to use as a occlusion balloon; this balloon helped stabilize the blood pressure; physician then decided to pull out coda balloon and introduce a 8fr x 55cm sheath to deploy a 8mm x 79mm vbx balloon expandable stent graft above the right common iliac artery in the infra renal aorta just above the bifurcation to create an aorto-uni-iliac device; a coda 32mm balloon was used to expand the 11mm vbx to 14-16mm; contrast was still observed flowing around the first vbx stent therefore a 2nd 11mm x 79mm vbx was deployed and ballooned with coda 32mm as well as a 14mm balloon catheter; contrast was still observed to be coming into the occulded left common iliac therefore a cook 24mm x 58mm esbe was opened and introduced over the right amplatz wireguide; the device did not advance due to sever iliac disease therefore the decision was made to introduce a gore dry seal 16fr x 33cm sheath after pulling out the 18fr esbe; once the 16fr x 33cm sheath was advanced over the amplatz wire guide a gore excluder 23mm x 33mm cuff was placed infra-renal aorta just 2cm proximal to the last 11mm x 79mm vbx. A small amount of contrast was observed leaking into the left common iliac therefore another gore excluder 26mm x 33mm cuff was deployed 2cm proximal to the 23mm x 33mm cuff successfully; very little contrast was seen leaking around the devices and pts bp seemed to stabilize without the need for aortic occlusion; physician then decided to expose the right common femoral for endarectomy and do a femoral to femoral bypass to profuse the left extremity. Patient outcome: the patient required additional procedures due to this occurrence: endovascular aorto-uni-iliac devices to excluded ruptured left external illiac artery; fem-fem bypass to restore blood flow to right leg.

 
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Brand NameZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA 4632
Manufacturer (Section G)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov DK-46 32
DA DK-4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov DK-46-32
DA   DK-4632
56868686
MDR Report Key7867756
MDR Text Key119926922
Report Number3002808486-2018-01071
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP140016
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/23/2019
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received09/12/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberG35349
Device Catalogue NumberZTA-P-34-113-W
Device LOT NumberE3706831
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date08/27/2018
Device Age5 mo
Event Location No Information
Date Manufacturer Received01/03/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/27/2018
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: 09/12/2018 Patient Sequence Number: 1
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