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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 PRE-SHAPED 45 150CM CATHETER, PERCUTANEOUS

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STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 PRE-SHAPED 45 150CM CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number M0031681900
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Headache (1880); Memory Loss/Impairment (1958); Paresis (1998); Dysphasia (2195); Thromboembolism (2654)
Event Date 06/25/2015
Event Type  Injury  
Manufacturer Narrative

The device was not available to the manufacturer. The device was disposed in the facility.

 
Event Description

It was reported that during an access to a target secular left supraclinoid carotid artery aneurysm; a peripheral thromboembolism occurred after a non-stryker distal access catheter was placed in the left m1 middle cerebral artery. The distal access catheter was advanced through a microcatheter (subject device). There was "flow stagnation in a frontal middle cerebral artery 2/3 branches", that was resolved after a total of 5. 0mg of verapamil and 10mg of reopro were administered. The procedure was aborted. The next day, neurological assessments found that the patient had a stroke with neurological deficit. It was observed that the patient had hemi-sensory deficit of left upper and left lower limb and dysphasia. However, magnetic resonance imaging (mri) showed "no abnormalities that would explain the aphasia. No infarct was visible. " two (2) days post procedure, the patient was discharged. The patient still had some dysphasia. The patient's modified rankin scale and a national institute of health stroke scale (nihss) were measured of 2. One week post procedure, the patient noted remaining difficulty finding words. The event was assessed as related to the procedure and the competitor distal access catheter. Twenty six (26) days post stent implant placement, the patient experienced a headache and memory disturbance. Magnetic resonance imaging (mri) showed complete occlusion of the target aneurysm. The physician suggested that "possibly the clotting process had inflammation aspects which might lead to deficit in perianeurysmal nerve tissue. The memory disturbance was probably caused by malfunction of the uncus hippocampi. This structure was directly in the perianeurysmal environment".

 
Manufacturer Narrative

The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications. The subject device was not returned; therefore, a physical as well as a functional evaluation could be performed. Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released. However, stroke, embolism, headache, and neurological deficits are known risks associated with endovascular procedure and noted as such in the device directions for use. Therefore, an assignable cause of anticipated procedural complication was assigned to this event.

 
Event Description

It was reported that during an access to a target secular left supraclinoid carotid artery aneurysm; a peripheral thromboembolism occurred after a non-stryker distal access catheter was placed in the left m1 middle cerebral artery. The distal access catheter was advanced through a microcatheter (subject device). There was ¿flow stagnation in a frontal middle cerebral artery 2/3 branches¿, that was resolved after a total of 5. 0mg of verapamil and 10mg of reopro were administered. The procedure was aborted. The next day, neurological assessments found that the patient had a stroke with neurological deficit. It was observed that the patient had hemi-sensory deficit of left upper and left lower limb and dysphasia. However, magnetic resonance imaging (mri) showed ¿no abnormalities that would explain the aphasia. No infarct was visible. ¿ two (2) days post procedure, the patient was discharged. The patient still had some dysphasia. The patient¿s modified rankin scale and a national institute of health stroke scale (nihss) were measured of 2. One week post procedure, the patient noted remaining difficulty finding words. The event was assessed as related to the procedure and the competitor distal access catheter. Twenty six (26) days post stent implant placement, the patient experienced a headache and memory disturbance. Magnetic resonance imaging (mri) showed complete occlusion of the target aneurysm. The physician suggested that "possibly the clotting process had inflammation aspects which might lead to deficit in perianeurysmal nerve tissue. The memory disturbance was probably caused by malfunction of the uncus hippocampi. This structure was directly in the perianeurysmal environment".

 
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Brand NameEXCELSIOR SL-10 PRE-SHAPED 45 150CM
Type of DeviceCATHETER, PERCUTANEOUS
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
sanda dracic
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key5332277
MDR Text Key34583758
Report Number3008853977-2015-00545
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeNL
PMA/PMN NumberK042568
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type STUDY
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/08/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/29/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/08/2017
Device Catalogue NumberM0031681900
Device LOT Number18493951
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/16/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/20/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/29/2015 Patient Sequence Number: 1
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