MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035421030
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Premature Separation (4045)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Dysphasia (2195); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device remained inside patient.
Event or Problem Description
It was reported that during procedure, the inzone detachment device was used to detach the subject coil.When the inzone detachment device indicated 3 beeps to detach, the subject coil could not be detached but one loop of the subject coil went out into the vessel and other side of the subject coil stuck in the distal end of the microcatheter resulting surgical delay.Finally, the subject coil has been detached and completed the procedure.No other information was provided.
Additional Manufacturer Narrative
B1 product problem: corrected: no product problem.B1 : updated to adverse event.B5 executive summary - updated.D4 expiration date - added.H4 manufacturing date ¿ added.F10 / h6 health effect - clinical code: updated.F10 / h6 health effect - impact code: updated.F10 / h6 medical device problem code: updated.
Event or Problem Description
It was reported that during procedure, the inzone detachment device was used to detach the subject coil.When the inzone detachment device indicated 3 beeps to detach, the subject coil could not be detached but one loop of the subject coil went out into the vessel and other side of the subject coil stuck in the distal end of the microcatheter resulting surgical delay.Finally, the subject coil has been detached and completed the procedure.No other information was provided.Update: further reviewing the event, there was no issue with detachment but seems the coil remained stuck in the distal of the microcatheter after detachment.Additional information was captured on 10-december that the patient is still at the hospital with hemiparesis and severe dysphasia.The patient¿s current condition is hemodynamically stable, good clinical evolution.Remains aphasic persists with right hemiparesis, improvement of right lower limb tone is evidenced.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection 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.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient, the device was prepared as per the dfu and continuous flush was set up and maintained throughout the clinical procedure.It is unknown at present if the patient was affected as a result of the event.The patient¿s current condition is unknown.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable will be assigned to this complaint.
Event or Problem Description
It was reported that during procedure, the inzone detachment device was used to detach the subject coil.When the inzone detachment device indicated 3 beeps to detach, the subject coil could not be detached but one loop of the subject coil went out into the vessel and other side of the subject coil stuck in the distal end of the microcatheter resulting surgical delay.Finally, the subject coil has been detached and completed the procedure.No other information was provided.Update: further reviewing the event, there was no issue with detachment but seems the coil remained stuck in the distal of the microcatheter after detachment.Additional information was captured on 10-december that the patient is still at the hospital with hemiparesis and severe dysphasia.The patient¿s current condition is hemodynamically stable, good clinical evolution.Remains aphasic persists with right hemiparesis, improvement of right lower limb tone is evidenced.
Additional Manufacturer Narrative
Section b5 executive summary : updated - received additional information indicated that on 4 day follow up, medical appointment on (b)(6) 2021, patient with improvement of the motor deficit in the right side of the body, without language impairment, without headache, without fever, with adequate evolution, has a comprehensive rehabilitation plan.The timeframe between the initial procedure with hemiparesis and severe dysphasia were approximately 24 hours after the procedure.
Event or Problem Description
It was reported that during procedure, the inzone detachment device was used to detach the subject coil.When the inzone detachment device indicated 3 beeps to detach, the subject coil could not be detached but one loop of the subject coil went out into the vessel and other side of the subject coil stuck in the distal end of the microcatheter resulting surgical delay.Finally, the subject coil has been detached and completed the procedure.No other information was provided.Update: further reviewing the event, there was no issue with detachment but seems the coil remained stuck in the distal of the microcatheter after detachment.Additional information was captured on 10-december that the patient is still at the hospital with hemiparesis and severe dysphasia.The patient¿s current condition is hemodynamically stable, good clinical evolution.Remains aphasic persists with right hemiparesis, improvement of right lower limb tone is evidenced.Second update : received additional information indicated that on 4 day follow up, medical appointment on (b)(6) 2021, patient with improvement of the motor deficit in the right side of the body, without language impairment, without headache, without fever, with adequate evolution, has a comprehensive rehabilitation plan.The timeframe between the initial procedure with hemiparesis and severe dysphasia were approximately 24 hours after the procedure.

• Brand Name: TARGET 360 NANO 1MM X 3CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 12375224
• Report Number: 3008881809-2021-00348
• Device Sequence Number: 14557475
• Product Code: HCG
• UDI-Device Identifier: 04546540697974
• UDI-Public: 04546540697974
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/15/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/20/2024
• Device Model Number: M0035421030
• Device Catalogue Number: M0035421030
• Device Lot Number: 22631084
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/05/2021
• Supplement Date Received by Manufacturer: 11/24/2021; 12/21/2021; 01/18/2022
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 12/20/2021; 01/17/2022; 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INZONE DEVICE (STRYKER); MICROCATHETER (UNKNOWN MANUFACTURER)
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 64 YR
• Patient Sex: Female