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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK UNKNOWN_NEUROVASCULAR_PRODUCT; CATHETER, PERCUTANEUOUS

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STRYKER NEUROVASCULAR CORK UNKNOWN_NEUROVASCULAR_PRODUCT; CATHETER, PERCUTANEUOUS Back to Search Results
Catalog Number UNK_NEU
Device Problem Peeled/Delaminated (1454)
Patient Problems Foreign Body Reaction (1868); Vasoconstriction (2126); Patient Problem/Medical Problem (2688)
Event Date 11/01/2015
Event Type  Injury  
Manufacturer Narrative
The subject device is not available.
 
Event Description
The american journal of neuroradiology published an article report of 2 biopsy-proved and 3 suspected cases of foreign body emboli after endovascular interventions.On the basis of 2 brain-biopsy cases that allowed in-depth histopathological examination, these foreign bodies appear to be related to "polyvinylpyrrolidone" (pvp) catheter coating.In relationship to this article, it was reported that a patient (case 5) underwent y-stent assisted coiling of a left middle cerebral artery (mca) aneurysm with single-groin access consisting of a 6f shuttle, navien 070, excelsior xt-27, and echelon-10 catheters.Embolization was notable for intraprocedural occlusion of 2 superior division frontal branches, with no immediate clinical sequelae.Transient episodes of right upper extremity parasthesia and spasm developed 2 weeks post embolization.Conventional angiography demonstrated recanalization of the aforementioned frontal branches.Mr imaging and mr spectroscopy showed multiple enhancing lesions throughout the left mca territory, the largest involving areas subserved by initially occluded branches.A course of oral corticosteroids was administered.Mr imaging 3 months after the event showed decreased perilesional edema and reduced enhancement.No further information is available regarding the this patient.
 
Manufacturer Narrative
A review of the device history record could not be performed because the lot number was not reported.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.The reported 'patient complications', 'vasospasm', and allergic reaction' are risk associated with endovascular procedure and are noted as such in the device directions for use; therefore, anticipated in nature.The event description in the article states that both stryker and competitor devices were used in the procedure and that the patient complications were observed/experienced 2 weeks post embolization.The article also indicate that foreign materials which appear to be related to 'polyvinylpyrrolidone' (pvp) may be associated to patient's outcome.Pvp is a hydrophilic polymer component of hydrolene, used for xt-27 coating.As the device was not returned, it cannot be determined if the foreign matter originated from the xt-27 device; therefore, the cause of the event noted in the article cannot be determined.
 
Event Description
The american journal of neuroradiology published an article report of 2 biopsy-proved and 3 suspected cases of foreign body emboli after endovascular interventions.On the basis of 2 brain-biopsy cases that allowed in-depth histopathological examination, these foreign bodies appear to be related to polyvinylpyrrolidone (pvp) catheter coating.In relationship to this article, it was reported that a patient (case 5) underwent y-stent assisted coiling of a left middle cerebral artery (mca) aneurysm with single-groin access consisting of a 6f shuttle, navien 070, excelsior xt-27, and echelon-10 catheters.Embolization was notable for intraprocedural occlusion of 2 superior division frontal branches, with no immediate clinical sequelae.Transient episodes of right upper extremity parasthesia and spasm developed 2 weeks post embolization.Conventional angiography demonstrated recanalization of the aforementioned frontal branches.Mr imaging and mr spectroscopy showed multiple enhancing lesions throughout the left mca territory, the largest involving areas subserved by initially occluded branches.A course of oral corticosteroids was administered.Mr imaging 3 months after the event showed decreased perilesional edema and reduced enhancement.No further information is available regarding the this patient.
 
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Brand Name
UNKNOWN_NEUROVASCULAR_PRODUCT
Type of Device
CATHETER, PERCUTANEUOUS
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
Manufacturer (Section G)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
Manufacturer Contact
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key5881436
MDR Text Key52274500
Report Number3008881809-2016-00123
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113778
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/20/2016
1 Device was Involved in the Event
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 Catalogue NumberUNK_NEU
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/20/2016
Initial Date FDA Received08/17/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received10/20/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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