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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM 3 EZ 4.5MM X 30MM - CE; STENT, INTRACRANIAL NEUROVASCULAR
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STRYKER NEUROVASCULAR CORK NEUROFORM 3 EZ 4.5MM X 30MM - CE; STENT, INTRACRANIAL NEUROVASCULAR Back to Search Results
Catalog Number M003EN3E45300
Device Problems Entrapment of Device (1212); Migration or Expulsion of Device (1395)
Patient Problem Muscle Weakness (1967)
Event Date 01/16/2020
Event Type  Injury  
Event Description
It was reported that during the procedure, when a previously placed coil was half inserted into the aneurysm, deployment of the subject stent was attempted.However, when withdrawing the stent delivery wire, the stent distal bumper got stuck at distal aspect of subject stent.The physician attempted to adjust the stent but this caused it to migrate a lot inside the patient anatomy and loose targeted position.The stent delivery wire was withdrawn causing an associated catheter to migrate out of the aneurysm and coil to be stretched and fractured.The physician tried to adjust the stent delivery wire and micro catheter but was unable and finally took the stent delivery wire out and the procedure was stopped.Based on additional information received, it was reported that the patient developed muscle weakness and was under temporary medication.It was also reported that the subject stent was still inside the patient's body.The procedure was not completed successfully and no further information is currently available.
 
Manufacturer Narrative
H4 manufacturing date ¿ added d4 expiration date - added the device was not returned therefore, visual and functional testing as well as physical analysis cannot be performed.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications as the product was unable to be analyzed as per nc 2325700.Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.As per the available information, the device was confirmed to be in good condition during preparation/prior to use on the patient and it was prepared as per the dfu.The patient¿s anatomy was moderately tortuous.The event description states 'when withdrawing the stent delivery wire, the stent distal bumper was stuck at distal of the stent and couldn't be taken out.During the adjusting, the stent migrated a lot and was apart from the aneurysm neck completely.The microcatheter was migrated out of aneurysm during withdrawing the stent delivery wire and the coil which was half inserted was stuck on the stent and couldn't be filled or withdrawn.After several tries the coil stretched and fractured in the vessel'.It is probable that the deployment of the subject stent and subsequent attempt to remove the sdw and coil caused the stent to dislodge and migrate.An assignable cause of procedural factors will be assigned to the reported events as the issue is associated with a product that meets design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
 
Event Description
It was reported that during the procedure, when a previously placed coil was half inserted into the aneurysm, deployment of the subject stent was attempted.However, when withdrawing the stent delivery wire, the stent distal bumper got stuck at distal aspect of subject stent.The physician attempted to adjust the stent but this caused it to migrate a lot inside the patient anatomy and loose targeted position.The stent delivery wire was withdrawn causing an associated catheter to migrate out of the aneurysm and coil to be stretched and fractured.The physician tried to adjust the stent delivery wire and micro catheter but was unable and finally took the stent delivery wire out and the procedure was stopped.Based on additional information received, it was reported that the patient developed muscle weakness and was under temporary medication.It was also reported that the subject stent was still inside the patient's body.The procedure was not completed successfully and no further information is currently available.
 
Event Description
It was reported that during the procedure, when a previously placed coil was half inserted into the aneurysm, deployment of the subject stent was attempted.However, when withdrawing the stent delivery wire, the stent distal bumper got stuck at distal aspect of subject stent.The physician attempted to adjust the stent but this caused it to migrate a lot inside the patient anatomy and loose targeted position.The stent delivery wire was withdrawn causing an associated catheter to migrate out of the aneurysm and coil to be stretched and fractured.The physician tried to adjust the stent delivery wire and micro catheter but was unable and finally took the stent delivery wire out and the procedure was stopped.Based on additional information received, it was reported that the patient developed muscle weakness and was under temporary medication.It was also reported that the subject stent was still inside the patient's body.The procedure was not completed successfully and no further information is currently available.
 
Manufacturer Narrative
H4 manufacturing date ¿ added.D4 expiration date - added.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.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 as the product was unable to be analyzed as per nc 2325700.As per the available information, the device was confirmed to be in good condition during preparation/prior to use on the patient and it was prepared as per the dfu.The patient¿s anatomy was moderately tortuous.The event description states 'when withdrawing the stent delivery wire, the stent distal bumper was stuck at distal of the stent and couldn't be taken out.During the adjusting, the stent migrated a lot and was apart from the aneurysm neck completely.The catheter was migrated out of aneurysm during withdrawing the stent delivery wire and the coil which was half inserted was stuck on the stent and couldn't be filled or withdrawn.After several tries the coil stretched and fractured in the vessel'.It is probable that the deployment of the stent and subsequent attempt to remove the sdw and coil caused the stent to dislodge and migrate.An assignable cause of procedural factors will be assigned to the reported events as the issue is associated with a product that meets design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
 
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Brand Name
NEUROFORM 3 EZ 4.5MM X 30MM - CE
Type of Device
STENT, INTRACRANIAL NEUROVASCULAR
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
IE  NA
MDR Report Key9668893
MDR Text Key177811380
Report Number3008881809-2020-00031
Device Sequence Number1
Product Code NJE
Combination Product (y/n)N
PMA/PMN Number
H020002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 03/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/21/2022
Device Catalogue NumberM003EN3E45300
Device Lot Number21464263
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/27/2020
Date Manufacturer Received03/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
EXCELSIOR XT-27 (STRYKER); SL-10 (STRYKER); SYNCHRO GUIDEWIRE (STRYKER); TARGET 360 SOFT (STRYKER)
Patient Outcome(s) Other; Required Intervention;
Patient Age44 YR
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