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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 3MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION
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STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 3MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION Back to Search Results
Catalog Number M0035423080
Device Problem Expulsion (2933)
Patient Problems Hemorrhage/Bleeding (1888); Rupture (2208)
Event Date 04/08/2021
Event Type  Injury  
Manufacturer Narrative
Device is not available to manufacturer.
 
Event Description
It was reported that during the procedure for aneurysm treatment of size 3.1mm*3.7mm, a microcatheter was delivered at the target location with the help of a guidewire.A first coil was inserted to fill the aneurysm however, this coil was not able to be framed normally so the physician decided to deploy a stent first.The first stent used to deploy was not able to go into the microcatheter with big resistance.Then delivered with force, the stent was deployed unexpectedly in hub.The stent was replaced and a new stent was deployed at the target location.The physician then used the coil (subject device) to frame the aneurysm.During the procedure the subject coil protruded out of aneurysm and then the aneurysm was ruptured.The subject coil was successfully placed back into the aneurysm and the physician continued to fill the aneurysm with additional coils.The patient was observed for about 30mins and then checked under angiography and showed no hemorrhage, so the physician completed the procedure.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 subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.The reported complaint was not confirmed and it cannot be confirmed that the device met specification, as the device was not returned.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.As per the available information during the procedure the coil protruded out of aneurysm and then the aneurysm was ruptured, the reason of the aneurysm rupture was because of the huge tension.It cannot be definitively determined that the aneurysm rupture was caused by the coil protrusion.The coil was successfully placed back into the aneurysm.As the device was not returned for analysis and a review and analysis of all available information fails to indicate an assignable cause or probable assignable cause, an assignable cause of undeterminable will be assigned to this complaint.
 
Event Description
It was reported that during the procedure for aneurysm treatment of size 3.1mm*3.7mm, a microcatheter was delivered at the target location with the help of a guidewire.A first coil was inserted to fill the aneurysm however, this coil was not able to be framed normally so the physician decided to deploy a stent first.The first stent used to deploy was not able to go into the microcatheter with big resistance.Then delivered with force, the stent was deployed unexpectedly in hub.The stent was replaced and a new stent was deployed at the target location.The physician then used the coil (subject device) to frame the aneurysm.During the procedure the subject coil protruded out of aneurysm and then the aneurysm was ruptured.The subject coil was successfully placed back into the aneurysm and the physician continued to fill the aneurysm with additional coils.The patient was observed for about 30mins and then checked under angiography and showed no hemorrhage, so the physician completed the procedure.No clinical consequences were reported to the patient due to this event.
 
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Brand Name
TARGET 360 ULTRA 3MM X 8CM
Type of Device
DEVICE, NEUROVASCULAR EMBOLIZATION
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
EI  NA
MDR Report Key11787886
MDR Text Key249454506
Report Number3008881809-2021-00187
Device Sequence Number1
Product Code HCG
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 08/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/12/2023
Device Catalogue NumberM0035423080
Was Device Available for Evaluation? No
Date Manufacturer Received08/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
EXCELSIOR XT17 MICROCATHETER (STRYKER); NEUROFORM EZ (STRYKER); REBAR27 MICROCATHETER (MEDTRONIC); SYNCHRO GUIDEWIRE (STRYKER); TARGET COILS (STRYKER)
Patient Outcome(s) Other;
Patient Age68 YR
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