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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 Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/04/2022
Event Type  malfunction  
Manufacturer Narrative
The device is not available to the manufacturer.
 
Event Description
It was reported that during the ruptured right supraclinoid dissecting aneurysm procedure, physician was advancing the subject flow diverting stent flipped the petals to resheath.He then deployed 7mm of the subject flow diverting stent and tried to drag drop from m1 to the ica terminus.The entire microcatheter and subject flow diverting stent fell down.While trying to resheath the physician has to use some force to advance microcatheter over distal opened subject flow diverting stent and was successful to capture 3mm and drag it out of the anatomy along with the microcatheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
 
Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The device was not returned for analysis, therefore visual and functional inspection was not performed.The reported event is covered in the device 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.The reported event was not confirmed and it cannot be confirmed if the device met specification, as the device was not returned.Additional information did not indicate any issues noted during unpacking or set up of the device, and the device was prepared as per dfu instructions.As the product was not returned, review and analysis of all available information fails to indicate an assignable cause or probable assignable cause for the reported event, an assignable cause of undeterminable will be assigned to this complaint of flow diverter stent difficult/unable to re-capture into microcatheter'.
 
Event Description
It was reported that during the ruptured right supraclinoid dissecting aneurysm procedure, physician was advancing the subject flow diverting stent flipped the petals to resheath.He then deployed 7mm of the subject flow diverting stent and tried to drag drop from m1 to the ica terminus.The entire microcatheter and subject flow diverting stent fell down.While trying to resheath the physician has to use some force to advance microcatheter over distal opened subject flow diverting stent and was successful to capture 3mm and drag it out of the anatomy along with the microcatheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
 
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Brand Name
UNKNOWN_NEUROVASCULAR_PRODUCT
Type of Device
INTRACRANIAL 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 Key14069764
MDR Text Key291313609
Report Number3008881809-2022-00165
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 Physician
Type of Report Initial,Followup
Report Date 07/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/25/2024
Device Catalogue NumberUNK_NEU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/30/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/26/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
PHENOM 27 MICROCATHETER (MEDTRONICS); SYNCHRO SELECT GUIDEWIRE (STRYKER)
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