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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1.5MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION
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STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1.5MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION Back to Search Results
Catalog Number M0035421530
Device Problems Migration or Expulsion of Device (1395); Premature Activation (1484)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/30/2018
Event Type  Injury  
Event Description
During the coil embolization procedure, it was reported that when the physician tried to remove the delivery wire after detachment attempt, the main coil was partially detached and came back with the delivery wire.Then the main coil was completed detached and went up into the brain.The physician tried to retrieve the main coil with the snare but it did not work, then the main coil was successfully removed from the patient with the stent retriever.The procedure took an extra hour and no clinical consequences reported to the patient.
 
Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.During the analysis of the returned device, it was revealed that the main coil was kinked, stretched and prematurely detached inside the patient.Functional testing could not be performed due to the condition of the returned device.Additional information indicates that the coil was confirmed to be in good condition after unpacking and preparation and there is no indication of a use error.Inspection of the main coil detachment zone indicates that the main coil was partially detached and then physically broke.It is likely that procedural factors contributed to the reported detachment issues and subsequent migration.Therefore an assignable cause of procedural factors will be assigned to the reported and analyzed defects.As the issue is associated with a product that meets the design and manufacture specifications and was used in accordance with the dfu (direction for use) but due to procedural and/or anatomical factors during use, the product performance was limited.
 
Event Description
During the coil embolization procedure, it was reported that when the physician tried to remove the delivery wire after detachment attempt, the main coil was partially detached and came back with the delivery wire.Then the main coil was completed detached and went up into the brain.The physician tried to retrieve the main coil with the snare but it did not work, then the main coil was successfully removed from the patient with the stent retriever.The procedure took an extra hour and no clinical consequences reported to the patient.
 
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Brand Name
TARGET 360 NANO 1.5MM X 3CM
Type of Device
DEVICE, NEUROVASCULAR EMBOLIZATION
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
Manufacturer (Section G)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
Manufacturer Contact
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key7640484
MDR Text Key112412604
Report Number3008881809-2018-00283
Device Sequence Number1
Product Code HCG
UDI-Device Identifier04546540697943
UDI-Public04546540697943
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153658
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 08/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2021
Device Catalogue NumberM0035421530
Device Lot Number20263780
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/11/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/31/2018
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
MICROCATHETER (UNKNOWN MANUFACTURER)
Patient Outcome(s) Required Intervention;
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