MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 6MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036126200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Speech Disorder (4415); Thrombosis/Thrombus (4440)
Date of Event	05/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the non occlusive thrombus occurred on (b)(6) 2024 post procedure before discharge as the patient experienced onset of slurred speech and right sided grip weakness.The outcome of the adverse event was resolved, without sequelae on the same day.According to the site, the adverse event was possibly related to the non study subject device and study disease; and causally related to the index procedure.Medications were provided to treat the adverse event.
Additional Manufacturer Narrative
Section b2 outcomes attributed to ae - updated (added: required intervention to prevent permanent impairment/damage (devices).
Event or Problem Description
It was reported that the non occlusive thrombus occurred on (b)(6) 2024 post procedure before discharge as the patient experienced onset of slurred speech and right sided grip weakness.The outcome of the adverse event was resolved, without sequelae on the same day.According to the site, the adverse event was possibly related to the non study subject device and study disease; and causally related to the index procedure.Medications were provided to treat the adverse event.
Event or Problem Description
It was reported that the non-occlusive thrombus occurred on (b)(6) 2024 post procedure before discharge as the patient experienced onset of slurred speech and right sided grip weakness.The outcome of the adverse event was resolved, without sequelae on the same day.According to the site, the adverse event was possibly related to the non-study subject device and study disease; and causally related to the index procedure.Medications were provided to treat the adverse event.Update: patient¿s current condition: patient was discharged home on (b)(6) 2024.Per edc (electronic data base) post procedure, before discharged ae1 (adverse event) non-occlusive thrombus was reported in the treated vascular territory.The patient had an onset of slurred speech and right sided grip weakness.It was considered as a suspected stroke and/or neurological event.The nihss (national institute of health stroke scale) at time of event was <=3 point worsening.Ct and cta (computed tomography angiography) were performed.Medication (tirofiban) was provided to prevent permanent impairment to body structure or a body function.Per procedure form no ae 9 adverse event) or device event was occurred during the procedure.Post procedure, before discharged ae1 non-occlusive thrombus was reported.Per the investigator-assessed relatedness the ae1 has possible relationship to the study device and non-study stryker devices.Condition was being treated: ruptured, left middle cerebral artery (mca) bifurcation aneurysm.Location of the treatment area: middle cerebral artery (mca) bifurcation.
Additional Manufacturer Narrative
Section a- age at time of event/ age units: added.Gender: added.Section b5 executive summary: updated.Section d catalog#: search/ product long description/ lot#: corrected from unknown to catalog#: m0036126200, target xl 360 soft 6mm x 20cm, and lot#: 24665042.Section d4: expiration date - added.Section e (initial reporter name/ initial reporter first and last name/ initial reporter address/ initial reporter city: updated.Section h4: manufacturing date ¿ added.Due to the automated mes ((manufacturing execution system) 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.It was reported that non occlusive thrombus occurred post procedure (within 48 hours) before the patient was discharged and the patient experienced slurred speech and right sided grip weakness.Medication was administered to the patient as a medical intervention.The outcome of the adverse event was resolved, without sequelae.The event details indicate that the adverse event was possibly related to the study device, non-study stryker device and study disease; and causally related to the index procedure.No device malfunction was reported.Based upon medical review, the harm observed in this complaint is anticipated in nature as per the device risk assessment.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 within the dfu, product labeling and/or risk documentation files, an assignable cause of anticipated procedural complication will be assigned to this complaint.

• Brand Name: TARGET XL 360 SOFT 6MM X 20CM
• 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: 19367024
• Report Number: 3008881809-2024-00223
• Device Sequence Number: 14402301
• Product Code: HCG
• UDI-Device Identifier: 07613327004625
• UDI-Public: 07613327004625
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/24/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: M0036126200
• Device Lot Number: 24665042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2024
• Supplement Date Received by Manufacturer: 05/24/2024; 07/01/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 06/04/2024; 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 48 YR
• Patient Sex: Male