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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 15MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 15MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number FD40015
Device Problem Activation Problem (4042)
Patient Problems Paralysis (1997); Obstruction/Occlusion (2422); Ischemia Stroke (4418)
Event Date 07/06/2021
Event Type  Injury  
Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release. The subject device is not available; therefore, functional testing as well as visual testing cannot be performed. The reported event is covered in the device directions for use (dfu). As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event. It was reported that during treatment of a wide neck intracranial aneurysm the subject stent did not open from its proximal portion, resulting in occlusion of the carotid artery and right sided sylvian ischemia resulting in left pyramidal syndrome including left hemiplegia. Additional information provided by the customer indicated that the device was confirmed to be in good condition before use, preparation/placement was performed according to the instructions for use, continuous flush was maintained throughout the procedure, the tortuosity of the patient's anatomy was normal as per images provided in the complaint, the stent size was appropriate for the treatment site, there was no stenosis and calcification of the lesion preoperatively, the stent was recaptured and repositioned one time, the catheter tip was not shaped, the microcatheter was directed at least 20 mm from the neck of the aneurysm, and there were no difficulties encountered during insertion, advancement or deployment of the stent. While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable will be assigned to this complaint. The device is not available to the manufacturer, as device is implanted in patient.
 
Event Description
It was reported that endovascular stent placement procedure was performed for the treatment of a wide neck intracranial aneurysm. Patient was reported to have normal tortuous vascular anatomy with no zero stenosis or calcification at the lesion. During the procedure, appropriate size stent was navigated to the target aneurysmal site with the help of the microcatheter which was placed distal to the neck of the aneurysm and position of the subject stent was confirmed under fluoroscopy by visualization of the radiopaque implants. After the microcatheter was slightly retracted to remove slack, the stent delivery microcatheter was retracted with a continuous motion during deployment while exerting slight forward pressure on the delivery wire. After one attempt of recapturing and repositioning the subject stent, when the subject stent was deployed at the targeted aneurysmal site, the stent did not open from its proximal portion. This resulted in the occlusion of the carotid artery and serious deterioration in health status. Patient was reported to have right-sided sylvian ischemia resulting in left pyramidal syndrome and left hemiplegia. The patient's hospitalization or extension of an existing hospitalization was reported due to this reported adverse event. Patient was advice to do regular follow up after 3 months. No follow-up procedure is rescheduled or the patient is not on any additional medication or treatment due to this reported issue. Patient outcome is ongoing.
 
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Brand NameSURPASS EVOLVE 4.0MM X 15MM - CE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
EI NA
Manufacturer (Section G)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
EI NA
Manufacturer Contact
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key12222258
MDR Text Key263408823
Report Number3008881809-2021-00312
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P170024/S003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 07/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberFD40015
Device Lot Number21778463R
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 Received07/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/23/2019
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: 07/23/2021 Patient Sequence Number: 1
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