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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 8MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

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STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 8MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION Back to Search Results
Model Number M0036128300
Device Problem Expulsion (2933)
Patient Problems Stroke/CVA (1770); Neurological Deficit/Dysfunction (1982)
Event Date 12/19/2019
Event Type  Injury  
Manufacturer Narrative
The subject device is unavailable to manufacturer.
 
Event Description
It was reported that during procedure, the subject coil was stretched during detachment and the detached coil protruded out of the aneurysm.The stent was placed to tack the proximal end of the coil down and completed the procedure.The following day (after procedure) patient found to have sudden onset of left sided weakness and right gaze preference.Stroke alert called and confirmed acute right frontal infarct.Heparin drip started and then discontinued about an hour later.Patient was monitored and improvement recognized with mild left sided weakness.The patient was discharged to rehab on (b)(6) 2019.No other information was provided.
 
Event Description
It was reported that during procedure, the subject coil was stretched during detachment and the detached coil protruded out of the aneurysm.The stent was placed to tack the proximal end of the coil down and completed the procedure.The following day (after procedure) patient found to have sudden onset of left sided weakness and right gaze preference.Stroke alert called and confirmed acute right frontal infarct.Heparin drip started and then discontinued about an hour later.Patient was monitored and improvement recognized with mild left sided weakness.The patient was discharged to rehab on (b)(6) 2019.No other information was provided.
 
Manufacturer Narrative
D4 expiration date: added.H4 manufacturing date: added.The edhr (electronic device history record) for the device lot is created and maintained in mes (manufacturing execution system).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 physical 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.Additional information provided by the customer indicated that no anomalies noted to the device prior to use and the product was prepared as per dfu.Also, continuous flush was maintained.Stent was also placed to tack the proximal end of the coil down.While there are a number of potential causes for the reported "main coil stretched, main coil protrusion", because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned.The reported "patient neurological deficit" and "patient stoke" are known and anticipated complications to these types of procedures and patient condition and are listed as such in the device directions for use.Therefore, a probable cause of anticipated procedural complication was assigned to this event.
 
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Brand Name
TARGET XL 360 SOFT 8MM X 30CM
Type of Device
DEVICE, NEUROVASCULAR EMBOLIZATION
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
IE  NA
MDR Report Key9561957
MDR Text Key176099259
Report Number3008881809-2020-00002
Device Sequence Number1
Product Code HCG
UDI-Device Identifier07613327004649
UDI-Public07613327004649
Combination Product (y/n)N
PMA/PMN Number
K153658
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 01/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/21/2021
Device Model NumberM0036128300
Device Catalogue NumberM0036128300
Device Lot Number20332535
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/23/2019
Initial Date FDA Received01/07/2020
Supplement Dates Manufacturer Received01/17/2020
Supplement Dates FDA Received01/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SL-10 MICROCATHETER (STRYKER)
Patient Outcome(s) Other; Required Intervention;
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