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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 2 MM X 4 CM; DEVICE, NEUROVASCULAR EMBOLIZATION
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STRYKER NEUROVASCULAR CORK TARGET 360 NANO 2 MM X 4 CM; DEVICE, NEUROVASCULAR EMBOLIZATION Back to Search Results
Catalog Number M0035442040
Device Problems Migration or Expulsion of Device (1395); Separation Problem (4043)
Patient Problems Aneurysm (1708); Thrombosis (2100); Rupture (2208)
Event Date 09/19/2019
Event Type  Injury  
Manufacturer Narrative
The subject device remains implanted.
 
Event Description
During treatment of anterior cerebral artery (aca) aneurysm, it was reported that the aneurysm ruptured after the deployment of the 5th coil.The compliant balloon was placed and inflated in the right a1 segment and the heparin was reversed to treat the rupture.The 6th coil was deployed and detached without issue.When the 7th subject device coil was deployed but produced a long cycle on detachment.It was presumed that the subject coil had not detached; therefore, the physician re-positioned (withdrawn slightly) the subject coil (and possibly the micro-catheter) to perform another detachment cycle; however, the subject coil had already detached.During re-positioning, an approximately 1cm of the subject coil tail migrated into the left a2 segment.At that time, no suitable retrieval devices were available, so the decision was made to deploy the stent to secure the subject coil tail.Thrombus formation was noted within the stent and the right a2 segment.The patient was administered with iv aspirin and reopro with good result.The patient was kept in icu overnight and is being slowly woken throughout the day today.No further information is available at this time.
 
Event Description
During treatment of anterior cerebral artery (aca) aneurysm, it was reported that the aneurysm ruptured after the deployment of the 5th coil.The compliant balloon was placed and inflated in the right a1 segment and the heparin was reversed to treat the rupture.The 6th coil was deployed and detached without issue.When the 7th subject device coil was deployed but produced a long cycle on detachment.It was presumed that the subject coil had not detached; therefore, the physician re-positioned (withdrawn slightly) the subject coil (and possibly the micro-catheter) to perform another detachment cycle; however, the subject coil had already detached.During re-positioning, an approximately 1cm of the subject coil tail migrated into the left a2 segment.At that time, no suitable retrieval devices were available, so the decision was made to deploy the stent to secure the subject coil tail.Thrombus formation was noted within the stent and the right a2 segment.The patient was administered with iv aspirin and reopro with good result.The patient was kept in icu overnight and is being slowly woken throughout the day today.No further information is available at this time.
 
Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned; therefore, physical 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.As the product was not returned and review and analysis of all available information fails to indicate an assignable cause or probable assignable cause for the reported "main coil protrusion";therefore, an assignable cause of undeterminable will be assigned.Based upon medical review assessment, the data reasonably suggest the clinical event is anticipated in nature and severity as per the dfu and does not require escalation to senior management.An assignable cause of anticipated procedural complication, will be assigned to the reported "patient aneurysm rupture" and "patient vessel thrombosis", as a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, product labeling and/or risk documentation files.
 
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Brand Name
TARGET 360 NANO 2 MM X 4 CM
Type of Device
DEVICE, NEUROVASCULAR EMBOLIZATION
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
MDR Report Key9147207
MDR Text Key161801096
Report Number3008881809-2019-00298
Device Sequence Number1
Product Code HCG
UDI-Device Identifier07613252600299
UDI-Public07613252600299
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 12/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/06/2022
Device Catalogue NumberM0035442040
Device Lot Number21196422
Was Device Available for Evaluation? No
Date Manufacturer Received11/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ATLAS STENT (STRYKER); MICROCATHTER (UNKNOWN MANUFACTURER); TARGET COILS (STRYKER); TRANSFORM BALLOON CATHETER (STRYKER)
Patient Outcome(s) Hospitalization; Other; Required Intervention;
Patient Age46 YR
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