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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 STANDARD 7MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION
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STRYKER NEUROVASCULAR CORK TARGET 360 STANDARD 7MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION Back to Search Results
Model Number M0035467150
Device Problems Expulsion (2933); Premature Separation (4045)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/13/2022
Event Type  Injury  
Manufacturer Narrative
The device is not available to the manufacturer.
 
Event Description
It was reported that during procedure the coil (subject device) prematurely detached.The coil (subject device) was not completely inside the aneurysm.Several stents retrievers and a snare were used as a medical intervention to retrieve the coil (subject device).The patient needed medication to prevent any clot forming around the coil (subject device).The procedure had to be abandon and the patient will come back again for a new attempt.The patient woke up without any deficits.No clinical consequences were reported to the patient due to this event.
 
Manufacturer Narrative
A2 patient information - age at time of event - added.A2 patient information - age units - added.A3 patient information - gender - added.H4 manufacturing date ¿ added.D4 expiration date - added.Due to the automated mes (manufacturing execution system) system, there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not 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.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.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 was assigned.
 
Event Description
It was reported that during procedure the coil (subject device) prematurely detached.The coil (subject device) was not completely inside the aneurysm.Several stents retrievers and a snare were used as a medical intervention to retrieve the coil (subject device).The patient needed medication to prevent any clot forming around the coil (subject device).The procedure had to be abandon and the patient will come back again for a new attempt.The patient woke up without any deficits.No clinical consequences were reported to the patient due to this event.
 
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Brand Name
TARGET 360 STANDARD 7MM X 15CM
Type of Device
DEVICE, NEUROVASCULAR EMBOLIZATION
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 Key14748362
MDR Text Key294423766
Report Number3008881809-2022-00301
Device Sequence Number1
Product Code HCG
UDI-Device Identifier07613252192602
UDI-Public07613252192602
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K153658
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 08/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM0035467150
Device Catalogue NumberM0035467150
Device Lot Number23482218
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/15/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age47 YR
Patient SexFemale
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