MAUDE Adverse Event Report: WILLIAM COOK EUROPE UNKNOWN; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number UNKNOWN

Device Problem Collapse (1099)

Patient Problem Diminished Pulse Pressure (2606)

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Based on journal article: bandorski et al."endograft collapse after endovascular treatment for thoracic aortic disease." cardiovasc intervent radiol.2010 jun;33(3):492-7.This complaint is related to (b)(4) also based on article.Catalog# is unknown but referred to as cook zeniththoracic device.Investigation is still in progress.

Event Description

Description of event according to article: a (b)(6) year old man, was involved in a road accident and sustained a traumatic aortic rupture, located directly distal to the origin of the left subclavian artery (lsa).A stent-graft (cook zenith; 32 x 120 mm) was inserted and the proximal end was placed distal to the origin of the left common carotid artery by covering the lsa.A 60% proximal oversizing was tolerated; a smaller graft was not immediately available.After 1 week the patient became anuric and the femoral pulse was no longer palpable.Angiography via the right brachial artery revealed collapse of the proximal stent-graft, with resulting reperfusion of the lsa.The collapsed proximal stent-graft was dilatated percutaneously with a transfemorally inserted 16-mm balloon catheter, followed by immediate recollapse of the graft.To stabilize the proximal end of the endograft a 20-mm nitinol stent was inserted via a transfemoral approach.Postinterventional angiography showed an expanded proximal stent-graft.Femoral pulses on both sites were palpable and renal function returned to normal.Ct scan after 2 months showed an expanded stent-graft.Patient outcome: the stent graft showed proximal collapse which lead to very reduced blood flow through the stent graft, resulting in anuria and no palpable femoral pulse.This was treated by dilatation (not successful) and insertion of a nitinol stent.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: this complaint addresses an event (related to patient number five listed in table 1) described in a journal article by bandorski et al.A 21-year-old man was involved in a road accident and sustained a traumatic aortic rupture, located directly distal to the origin of the lsa.A stent-graft (cook zenith; 32 x 120 mm) was inserted and the proximal end was placed distal to the origin of the left common carotid artery by covering the lsa.A 60% proximal oversizing was tolerated as a smaller graft was not immediately available.After 1 week the patient became anuric and the femoral pulse was no longer palpable.Angiography via the right brachial artery revealed collapse of the proximal stent-graft, with resulting reperfusion of the lsa.The collapsed proximal stent-graft was dilatated with a balloon catheter, followed by immediate recollapse of the graft.To stabilize the proximal end of the endograft a 20-mm nitinol stent was inserted.Postinterventional angiography showed an expanded proximal stent-graft.Femoral pulses on both sites were palpable and renal function returned to normal.Ct scan after 2 months showed an expanded stent-graft.The thoracic endovascular aortic repair (tevar) in which the complaint device was implanted was performed in the period between 2001 and 2006.Lot - or catalogue number of the complaint device was not described in the article.Consequently, based on the information and images available in the article, it is concluded that the device is most likely a tx2 device (i.E.Zteg-2p- device).A clinical assessment of the information available in the article was performed for the investigation.As per the assessment, this case does not show any fault or failure of the device, but was likely caused by the oversizing of the endograft.In young patients, treated for trauma, the native aorta is usually small diameter (around 20mm) and the radius of the lesser (inferior) curvature of the aortic arch is smaller and tighter.This means that endografts have trouble conforming to the inner radius of the aortic arch, and project upwards away from the wall of the aorta.This allows perfusion between the aortic wall and the endograft (type 1a endoleak) and if the blood pressure is sufficient, subsequent collapse of the endograft, as happened in this case.As stated in the article, a 60% proximal oversizing was tolerated and the device was reportedly a 32 mm diameter device.From this information, it is deduced that the proximal native fixation site would have been approximately 20mm in diameter.For a graft diameter of 32mm the intended aortic vessel diameter listed in the ifu is 28mm/29mm (14.3% / 10.3% oversizing respectively).As per ifu, the choice of diameter should be determined from the outer wall to outer wall vessel diameter.Undersizing or oversizing may result in incomplete sealing or compromised flow.Additionally, improper component placement, component migration and occlusion, and renal complications are listed as possible adverse events in the ifu.The ifu recommends a radius of curvature greater than 35 mm along the entire length of aorta intended to be treated.No information regarding radius of curvature or further information regarding the patients anatomy is provided in the article.The complaint is confirmed based on the information in the article.Blunt thoracic aortic injury was not included in the indication for tx2 devices and it has not been possible to establish a cause for this the event.However, user error (i.E.Patient selection) likely contributed to the occurrence, as the endograft was oversized for the patient's anatomy significantly more than recommended in the ifu.Cook will reopen the complaint if further information becomes available.No evidence to suggest that the device was not manufaturer according to specifications.Cook medical 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: UNKNOWN
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 8900589
• MDR Text Key: 154545109
• Report Number: 3002808486-2019-01213
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,other
• Type of Report: Initial,Followup
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/24/2019
• Initial Date FDA Received: 08/16/2019
• Supplement Dates Manufacturer Received: 01/21/2020
• Supplement Dates FDA Received: 02/05/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention