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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK UNKNOWN_NEUROVASCULAR_PRODUCT INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK UNKNOWN_NEUROVASCULAR_PRODUCT INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number UNK_NEU
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Intracranial Hemorrhage (1891)
Event Date 01/29/2021
Event Type  Injury  
Manufacturer Narrative
Although the lot number was not provided, the automated manufacturing execution system (mes) has controls in the manufacturing process to ensure the product met specifications upon release. The subject device is not available; therefore, visual as well as functional analysis 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 the procedure, proximal vasospasm which was not related to the subject stent was observed in the patient's anatomy. The patient was brought back two days post procedure and it was reported that the patient had multiple hemorrhages in the distal anterior circulation (not near the subject stent). Additional information received on 26-feb-2021 indicated that the device performed as intended and in the physician's opinion the event was not related to the subject device. Based upon medical review, the harm observed in the complaint is anticipated in nature as per the device risk assessment. An assignable cause of anticipated procedural complication will be assigned to the reported patient intracranial hemorrhage as a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted within the directions for use, product labelling and/or risk documentation files.
 
Event Description
It was reported that during the procedure on (b)(6) 2021, physician used the subject flow diverting stent to access target lesion radially. During the procedure, proximal vasospasm was observed in the patient¿s anatomy. It was confirmed that the proximal vasospasm was not related to the subject stent and was related to a micro catheter of different company used during the procedure. Two days post procedure, on (b)(6) 2021, the patient was brought back and contrast imaging was performed which showed multiple hemorrhages in the distal anterior circulation. It was confirmed that those hemorrhages were not near the subject stent. It is suspected that the patient passed away but it¿s not due to the stryker device. No further information is available.
 
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Brand NameUNKNOWN_NEUROVASCULAR_PRODUCT
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 Key11389220
MDR Text Key233972717
Report Number3008881809-2021-00104
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
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 02/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_NEU
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 Received01/31/2021
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 Treatment Data
Date Received: 02/26/2021 Patient Sequence Number: 1
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