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

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.

Manufacturer Narrative

Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of (b)(4) (importer).Manufacturers ref#: (b)(4).Name and address for importer site: (b)(4).Summary of investigational findings: this complaint focuses on advancement difficulty related to zta-p-34-133-w.It was reported that the difficulty was noted when resistance was felt, and the product could not pass the common iliac artery.Angioplasty was performed at this area multiple times along with multiple attempts to advance zta- p-34-133-w, however; without being able to pass the same area.The final attempt of advancing the zta-p-34-133-w was after implanted viabahn (endo conduit).During this attempt, the device was pulled back under fluoroscopy and it was discovered that the viabahn had been dragged down with the device.At this point the patient¿s pressure dropped and the product was immediately taken out of the patient.The device was observed to have the entire lt external iliac artery with viabahn stuck to the sheath of the device.The physician immediately placed a coda 32mm to use as an occlusion balloon.The balloon helped stabilize the blood pressure.Vbx balloon expandable stent graft above the rt common iliac artery was thereafter implanted.The procedure was completed with the use of other devices and performing femoral to femoral bypass to profuse the lt extremity.For the investigation, pre-implantation cta chest scan followed by a pre-implantation cta abdomen and pelvic scan, selected implantation images along with photographs of the removed device were provided.Per review of the provided imaging, inability to advance the zta-p-34-133-w through the left iliac arteries is confirmed.Although angioplasty improved the lumen, the introduction system advancement was still prevented by friction against severely calcified and recoiled plaque, and pre-existing stent.According to the imaging, the left external iliac artery was moderately to severely narrowed by eccentric, densely calcified plaque that spiraled along the artery¿s entire length.The mean diameter of external iliac was 6.4 mm.Minimum lumen diameter was 3.1 mm.The likely cause for the advancement inability is related to incompatible size of access vessel lumen with the outer size of the introduction system as the outer diameter of zta-p-34-133-w is 7.1 mm.As per ifu, adequate iliac or femoral access is required to introduce the device into the vasculature.Careful evaluation of vessel size, anatomy, and disease state is also required to ensure successful sheath introduction and subsequent withdrawal, as vessels that are significantly calcified, occlusive, tortuous, or thrombus lined may preclude introduction of the endovascular graft and/or increase the risk of embolization.The photographs of the removed introduction system demonstrate an avulsed segment of artery over the transition between the introducer tip and the distal introducer sheath as also described in the reported information for this complaint.This avulsion cannot be excluded from being a cascade effect of the experienced advancement inability.No evidence to suggest that this device was not manufactured according to specifications.(b)(4) will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 7867756
• MDR Text Key: 119926922
• Report Number: 3002808486-2018-01071
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002353494
• UDI-Public: (01)10827002353494(17)210327(10)E3706831
• Combination Product (y/n): N
• PMA/PMN Number: P140016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2021
• Device Model Number: G35349
• Device Catalogue Number: ZTA-P-34-113-W
• Device Lot Number: E3706831
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/27/2018
• Device Age: 5 MO
• Initial Date Manufacturer Received: 08/27/2018
• Initial Date FDA Received: 09/12/2018
• Supplement Dates Manufacturer Received: 01/03/2019
• Supplement Dates FDA Received: 01/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Weight: 71