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

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.

• 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 Key: 5881436
• MDR Text Key: 52274500
• Report Number: 3008881809-2016-00123
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113778
• Number of Events Reported: 1
• 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 Number: UNK_NEU
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2016
• Initial Date FDA Received: 08/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/20/2016
• 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 Number: 1
• Patient Outcome(s): Other; Required Intervention