MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 3D 5MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036155100
Medical Device Problem Codes	Fracture (1260); Expulsion (2933)
Health Effect - Clinical Codes	Vasoconstriction (2126); Movement Disorder (4412); Speech Disorder (4415); Embolism/Embolus (4438)
Date of Event	11/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during procedure at right internal carotid artery-ophthalmic, the subject coil was fractured, as the subject coil was stretched and dislocation.Therefore, the stent was used as jailing technique which caused the procedure prolonged approximately 60 minutes and inpatient hospitalization.After the study procedure, but within 48 hours after procedure, the patient experienced with word finding disorder and fine motor disorder left hand.The outcome was resolved, without sequelae.Raymond score post procedure was 2 - residual neck/dog ear defined as the persistence of any portion of the original defect of the arterial wall.
Event or Problem Description
It was reported that during procedure at right internal carotid artery-ophthalmic, the subject coil was fractured, as the subject coil was stretched and dislocation.Therefore, the stent was used as jailing technique which caused the procedure prolonged approximately 60 minutes and inpatient hospitalization.After the study procedure, but within 48 hours after procedure, the patient experienced with word finding disorder and fine motor disorder left hand.The outcome was resolved, without sequelae.Raymond score post procedure was 2 - residual neck/dog ear defined as the persistence of any portion of the original defect of the arterial wall.Update: additional information received on 5-dec-2024 stated that patient also experienced multiple micro embolic infarctions on the right, few on the left side resulting in word finding disorder and fine motor disorder left hand.The patient neurological assessment on (b)(6) 2024 showed mrs (modified rankin score) score of 2 and nihss (national institute of health stroke scale) score of 4.
Additional Manufacturer Narrative
Section b5 executive summary: updated ¿patient experienced multiple micro embolic infarctions on the right, few on the left side resulting in word finding disorder and fine motor disorder left hand¿.Section d catalog#: correct to ¿m0036155100¿.Search/ lot/serial#: corrected to ¿(b)(6)¿.D4 gtin: added: '(b)(4)'.D4 expiration date: added.G4 pma/510(k): corrected to k123377.H4 manufacturing date: added.F10/h6 clinical signs code grid: added 'thromboembolism'.
Event or Problem Description
It was reported that during procedure at right internal carotid artery-ophthalmic, the subject coil was fractured, as the subject coil was stretched and dislocation.Therefore, the stent was used as jailing technique which caused the procedure prolonged approximately 60 minutes and inpatient hospitalization.After the study procedure, but within 48 hours after procedure, the patient experienced with word finding disorder and fine motor disorder left hand.The outcome was resolved, without sequelae.Raymond score post procedure was 2 - residual neck/dog ear defined as the persistence of any portion of the original defect of the arterial wall.Update: additional information received on (b)(6) 2024 stated that patient also experienced multiple micro embolic infarctions on the right, few on the left side resulting in word finding disorder and fine motor disorder left hand.The patient neurological assessment on (b)(6) 2024 showed mrs (modified rankin score) score of 2 and nihss (national institute of health stroke scale) score of 4.
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 complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product 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.The reported adverse are known and anticipated complication to these types of procedures and patient condition and are listed as such in the device directions for use.However it is unclear if the reported device issues caused or contributed to the ae.While there are a number of potential causes for the reported issues, because the product was not returned, review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned.
Additional Manufacturer Narrative
Section b executive summary: updated.F10/h6 clinical signs code grid: added vasoconstriction.F10/h6 health impact code grid: added ' medication required'.
Event or Problem Description
It was reported that during procedure at right internal carotid artery-ophthalmic, the subject coil was fractured, as the subject coil was stretched and dislocation.Therefore, the stent was used as jailing technique which caused the procedure prolonged approximately 60 minutes and inpatient hospitalization.After the study procedure, but within 48 hours after procedure, the patient experienced with word finding disorder and fine motor disorder left hand.The outcome was resolved, without sequelae.Raymond score post procedure was 2 - residual neck/dog ear defined as the persistence of any portion of the original defect of the arterial wall.Update: additional information received on 5-dec-2024 stated that patient also experienced multiple micro embolic infarctions on the right, few on the left side resulting in word finding disorder and fine motor disorder left hand.The patient neurological assessment on (b)(6) 2024 showed mrs (modified rankin score) score of 2 and nihss (national institute of health stroke scale) score of 4.Second update: additional information received on 15-may-2025 sated that during procedure, super-selective probing of the right internal carotid artery with a catheter.After probing, strong vasospasm of the right ica.It was entirely resolved via infusion of nimodipine with the flushing fluid over several minutes.Vasospasm of the right ica also occurred two more times later on, but each time it resolved completely with nimodipine.
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 complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product 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.The reported adverse events are known and anticipated complication to these types of procedures and patient condition and are listed as such in the device directions for use.However, it is unclear if the reported device issues caused or contributed to the adverse event.While there are a number of potential causes for the reported issues, because the product was not returned, review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned.
Event or Problem Description
It was reported that during procedure at right internal carotid artery-ophthalmic, the subject coil was fractured, as the subject coil was stretched and dislocation.Therefore, the stent was used as jailing technique which caused the procedure prolonged approximately 60 minutes and inpatient hospitalization.After the study procedure, but within 48 hours after procedure, the patient experienced with word finding disorder and fine motor disorder left hand.The outcome was resolved, without sequelae.Raymond score post procedure was 2 - residual neck/dog ear defined as the persistence of any portion of the original defect of the arterial wall.Update: additional information received on 5-dec-2024 stated that patient also experienced multiple micro embolic infarctions on the right, few on the left side resulting in word finding disorder and fine motor disorder left hand.The patient neurological assessment on (b)(6) 2024 showed mrs (modified rankin score) score of 2 and nihss (national institute of health stroke scale) score of 4.Second update: additional information received on 15-may-2025 sated that during procedure, super-selective probing of the right internal carotid artery with a catheter.After probing, strong vasospasm of the right ica.It was entirely resolved via infusion of nimodipine with the flushing fluid over several minutes.Vasospasm of the right ica also occurred two more times later on, but each time it resolved completely with nimodipine.

• Brand Name: TARGET 3D 5MM X 10CM
• 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: 20888962
• Report Number: 3008881809-2024-00586
• Device Sequence Number: 21066326
• Product Code: HCG
• UDI-Device Identifier: 04546540711687
• UDI-Public: (01)04546540711687(17)270525(10)24982779
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K123377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/02/2025

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 Catalogue Number: M0036155100
• Device Lot Number: 24982779
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 12/05/2024; 01/24/2025; 05/15/2025; 06/18/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 12/26/2024; 02/10/2025; 05/22/2025; 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/26/2024
• 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: EXCELSIOR 1018 MICROCATHETER (STRYKER).; NEUROFORM ATLAS STENT (STRYKER).; SCEPTER XC BALLOON CATHETER.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 70 KG