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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK UNKNOWN_NEUROVASCULAR_PRODUCT CATHETER, PERCUTANEOUS

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STRYKER NEUROVASCULAR CORK UNKNOWN_NEUROVASCULAR_PRODUCT CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number UNK_NEU
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Aneurysm (1708); Hemorrhage, Cerebral (1889); Rupture (2208)
Event Date 02/04/2015
Event Type  Injury  
Manufacturer Narrative
The device is not available to the manufacturer.
 
Event Description
It was reported in the literature article that a stent assisted coil embolization procedure was performed to treat a basilar artery aneurysm. While the subject microcatheter was being advanced to the target lesion, it perforated the aneurysm. The physician stated that the tortuosity of the left vertebral artery contributed to the reported adverse event. The procedure was completed with a stent placement and coil embolization of the aneurysm. The bleeding was stopped after the aneurysm embolization was completed. No further information was provided.
 
Manufacturer Narrative
The device was not available for analysis. Based on the information available it is most likely that the patient¿s tortuous anatomy contributed to the reported vessel perforation. The issue was associated with a product that met design and manufacture specifications and was used according to the dfu but due to anatomical factors, performance was limited. Therefore, it was determined that the reported event was related to operational context.
 
Event Description
It was reported in the literature article that a stent assisted coil embolization procedure was performed to treat a basilar artery aneurysm. While the subject microcatheter was being advanced to the target lesion, it perforated the aneurysm. The physician stated that the tortuosity of the left vertebral artery contributed to the reported adverse event. The procedure was completed with a stent placement and coil embolization of the aneurysm. The bleeding was stopped after the aneurysm embolization was completed. No further information was provided.
 
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Brand NameUNKNOWN_NEUROVASCULAR_PRODUCT
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
bertha paulo
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key4507619
MDR Text Key12887157
Report Number3008853977-2015-00052
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K113778
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/04/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2015
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
Date Manufacturer Received03/10/2015
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: 02/11/2015 Patient Sequence Number: 1
Treatment
COILS (MODEL AND MANUFACTURER UNKNOWN); NEUROFORM EZ STENT (STRYKER)
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