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COOK INC ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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| Catalog Number ZSLE-13-56-ZT |
| Device Problems
Material Disintegration (1177); Flaked (1246)
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| Patient Problems
Infarction, Cerebral (1771); Death (1802); Seizures (2063)
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Event Type
Death
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Manufacturer Narrative
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(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
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Event Description
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It was reported that hydrophilic polymer embolized after fragmenting off a zenith flex with spiral-z technology aaa endovascular graft iliac leg introduction sheath.A (b)(6) year old woman underwent a two-stage procedure to treat a 6 cm diameter degenerative extent ii thoracoabdominal aortic aneurysm.She first underwent a left carotid-subclavian transposition, which she tolerated well.Three months later, she returned to the hospital to have her aneurysm treated.Following a midline laparotomy and isolation of the abdominal aorta, a right ilioceliac bypass was done with a 6-mm pete graft, and the celiac trunk ostium was ligated.Given the small iliac arteries, a 10-mm pete graft was sewn end to side to the right common iliac artery as a conduit.The first stent graft, a cook zenith alpha (zta-pt 32-155) [reported with mdr# 3002808486-2019-01779], was deployed in zone 2, covering the origin of the left subclavian artery.Two custom stent grafts were then deployed with perfusion branches in the thoracic aorta and an sma branch graft in the abdominal aorta.An iliac branch extension was inserted into the right common iliac artery (zsle 13-56) [subject of this report].The completion angiogram demonstrated a good seal.Retrograde cannulation of the sma was done to gain access into the tevar branch.This was bridged with two atrium advanta v12 stents.After this, the sma arteriotomy was closed primarily.Last, the right iliac conduit was sewn onto the left common iliac artery, essentially forming an iliac-iliac crossover graft because the proximal left common iliac artery was covered by the endograft.The patient immediately developed seizure postoperatively and deteriorated on pod 2 when her neurologic responses did not recover.A non-contrast-enhanced ct head scan and magnetic resonance imaging revealed restricted diffusion in the left frontal cortex, in keeping with an acute infarction, as well as several microbleeds but no occlusion of the middle cerebral artery.Her condition continued to worsen and was made comfort care on pod 5.Autopsy examination confirmed hydrophilic polymer microemboli scattered throughout the brain.Fragments of polymer coating were identified in the right kidney with associated infarction and glomerulosclerosis of nearly half the parenchyma.Given her already compromised renal function, this was thought to have contributed to her failing health; however, compared with her neurologic symptoms and findings, her renal failure was unlikely to be the cause of death.Last, emboli were also discovered embedded in the aortic adventitia and liver.Yang, gary k., et al.¿hydrophilic polymer embolization after thoracic endovascular aortic repair.¿ journal of vascular surgery cases and innovative techniques, vol.5, no.4, 2019, pp.423¿426., doi:10.1016/j.Jvscit.2019.05.002.
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Event Description
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No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
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Manufacturer Narrative
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Correction: h6- device code.Investigation / evaluation: (b)(4), located in canada, informed cook on (b)(6) 2019 of an article, ¿hydrophilic polymer embolization after thoracic endovascular aortic repair¿, featured in the journal of vascular surgery cases and innovative techniques, which mentions an incident involving a zenith flex with spiral-z technology aaa endovascular graft iliac leg (rpn: zsle-13-56-zt).In the article, case report two, the author describes that a patient had hydrophilic polymer micro emboli scattered throughout the brain and right kidney that caused renal failure after an endovascular aortic repair (evar), leading to patient death.A review of documentation including the complaint history, device history record (dhr), drawing, instructions for use (ifu), quality control, and specifications of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the design history file (dhf) showed that this device is both safe and effective for its intended use.A review of the dhr was unable to be completed as the lot number for the device was not provided within the article.A review of sales to the customer could not be completed to identify the lot number as the implant date was also not provided.It should be noted that zsle devices are distributed via one-device lots, giving no indication of nonconforming product in house.With the available information, cook has concluded that the device was manufactured to specification and that there is no evidence of nonconforming product either in house or in field.Cook also reviewed product labeling.The current product instructions for use (ifu), [t_zaaasz_rev4] ¿zenith® spiral-z aaa iliac leg with the z-trak¿ introduction system¿, provides the following information to the user related to the reported failure mode: ¿4 warnings and precautions 4.5 implant procedure ¿ to activate the hydrophilic coating on the outside of the flexor introducer sheath, the surface must be wiped with sterile gauze pads soaked in saline solution.Always keep the sheath hydrated for optimal performance.¿ the use of the zenith spiral-z aaa iliac leg with the z-trak introduction system requires administration of intravascular contrast.Patients with pre-existing renal insufficiency may have an increased risk of renal failure postoperatively.Care should be taken to limit the amount of contrast media used during the procedure and to observe preventative methods of treatment to decrease renal compromise (e.G., adequate hydration).5 adverse events 5.2 potential adverse events adverse events that may occur and/or require intervention include, but are not limited to: ¿ death ¿ embolization (micro and macro) with transient or permanent ischemia or infarction 9 how supplied ¿ the zenith spiral-z aaa iliac leg is loaded onto a 14 or 16 french flexor introducer sheath.The sheath¿s surface is treated with a hydrophilic coating that, when hydrated, enhances trackability.To activate the hydrophilic coating, the surface must be wiped with a sterile gauze pad soaked in saline solution under sterile conditions.11 directions for use 11.1 zenith spiral-z aaa iliac leg system 11.1.1 contralateral iliac leg preparation/flush 3.Soak sterile gauze pads in saline solution and use to wipe flexor introducer sheath to activate the hydrophilic coating.Hydrate both sheath and dilator liberally.11.1.2 ipsilateral iliac leg preparation/flush follow the instructions in the previous section, contralateral iliac leg preparation/flush, to ensure proper flushing of the ipsilateral iliac leg graft and activation of the hydrophilic coating.¿ based on the information provided, no product returned, and the results of the investigation, a definitive root cause of failure could not be established.Multiple devices were used during the procedure, which may have also had hydrophilic coating.In the article, the author theorizes that a larger hydrophilic coated device kept inside a patient for a longer amount of time would have a higher risk at having its hydrophilic coating coming off than a smaller device kept in a patient for a shorter amount of time.It is unknown if devices with larger hydrophilic coated components than the complaint device¿s sheath were used during the procedure.No evidence was available to assist with identifying what device the hydrophilic coating emboli came from.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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