MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1MM X 2CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035421020
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after left supraclinoid aneurysm embolization procedure, after detaching the subject coil, when physician attempted to remove microcatheter from the aneurysm, the subject coil was attached to the microcatheter and got dislodged from the aneurysm.The subject coil was then successfully removed from the body using manual aspiration with a 60cc syringe.The procedure was completed successfully, and the patient was stable post-procedure.
Additional Manufacturer Narrative
H3 device evaluated by mfg ¿updated.Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.During visual and microscopic inspection, it was observed that the subject coil introducer sheath and coil delivery wire was not returned.The subject main coil was returned protruding from the catheter tip and the subject main coil was kinked and stretched.The distal ball was intact.Functional test revealed that the concurrent catheter could not be flushed, an attempt to advance a 0.0158" patency mandrel was made; however, due to the damage to the catheter the patency could not be advanced though the entire catheter shaft.Force was applied and the subject coil deployed from the catheter tip.There was dried blood/procedural fluid on the proximal of the main coil and the coil was submerged in warm water to remove the blood/procedural fluid.The coil detachment area was damaged, and the coil appeared to be electrolytically detached.The catheter tip was intact.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 was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that the subject coil was successfully detached but during removal of the microcatheter from the coil mass, the final coil moved and appeared to be attached to the microcatheter tip.Based on the condition of the returned devices it is likely that the subject coil was detached inside the microcatheter tip but due to the damage to the main coil junction it got stuck inside the microcatheter.This then resulted in movement/migration of the subject coil.Based on the information provided the device was in good condition prior to use and appears to have been used in accordance with the dfu.An assignable cause of procedural factors will be assigned to the as reported codes device interaction with another device, main coil migration and as analyzed codes coil jammed', ¿main coil kinked/bent', 'main coil stretched' and 'main coil damaged.The issue is associated with a product that meets stryker design and manufacture specifications and was used in accordance with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
It was reported that after left supraclinoid aneurysm embolization procedure, after detaching the subject coil, when physician attempted to remove microcatheter from the aneurysm, the subject coil was attached to the microcatheter and got dislodged from the aneurysm.The subject coil was then successfully removed from the body using manual aspiration with a 60cc syringe.The procedure was completed successfully, and the patient was stable post-procedure.

• Brand Name: TARGET 360 NANO 1MM X 2CM
• 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: 19712616
• Report Number: 3008881809-2024-00301
• Device Sequence Number: 8514060
• Product Code: HCG
• UDI-Device Identifier: 04546540697967
• UDI-Public: 04546540697967
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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
• Report Date (Section B): 09/16/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/05/2025
• Device Catalogue Number: M0035421020
• Device Lot Number: 23568043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2024
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2022
• 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 SL-10 MICROCATHETER (STRYKER).; SYNCHRO GUIDEWIRE (STRYKER).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown