MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 3D 4MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036154080
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is 2 of 2 reports (2nd mdr).
Event or Problem Description
It was reported that during a coil embolization procedure for a 4 mm aneurysm was about to be treated without a stent.A microcatheter was guided into the aneurysm, and the first coil (subject device) and second coil were implanted.However, during the insertion of the third, it did not engage with the mass, and while repositioning the third coil, it became entangled with near the tip of the first subject coil implanted and made a knot, making it impossible to retrieve the third coil.While pushing and pulling the third coil to untie the knot, the subject coil deviated from the mass, and a stent that was not planned to use had to be used.By pushing and pulling the coils, the knot was untied, and the third coil was managed to be retrieved.Three additional coils were inserted into the aneurysm and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.However, as a stent was used, the patient will require long-term medication.The extended operative time also resulted in increased radiation exposure.The patient¿s current condition is stable.
Additional Manufacturer Narrative
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 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 because the product was not returned.Based on the information provided in the complaint, the coil appears to have been successfully deployed in the aneurysm but during placement of a subsequent coil, both coils got tangled and the subject coil was partially pulled into the parent vessel where a stent had to be deployed to prevent further migration.The associated coil was returned for complaint analysis and was found to be intact.The subject coil was not returned so it cannot be determined if the coil contributed to the reported event.An assignable cause of undeterminable will be assigned 'main coil tangled', 'main coil migration', 'device interaction with another device'.The product was not returned and review and analysis of all available information fails to indicate an assignable cause or probable assignable cause.
Event or Problem Description
It was reported that during a coil embolization procedure for a 4 mm aneurysm was about to be treated without a stent.A microcatheter was guided into the aneurysm, and the first coil (subject device) and second coil were implanted.However, during the insertion of the third, it did not engage with the mass, and while repositioning the third coil, it became entangled with near the tip of the first subject coil implanted and made a knot , making it impossible to retrieve the third coil.While pushing and pulling the third coil to untie the knot, the subject coil deviated from the mass, and a stent that was not planned to use had to be used.By pushing and pulling the coils, the knot was untied, and the third coil was managed to be retrieved.Three additional coils were inserted into the aneurysm and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.However, as a stent was used, the patient will require long-term medication.The extended operative time also resulted in increased radiation exposure.The patient¿s current condition is stable.

• Brand Name: TARGET 3D 4MM X 8CM
• 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: 20212871
• Report Number: 3008881809-2024-00420
• Device Sequence Number: 12594597
• Product Code: HCG
• UDI-Device Identifier: 04546540711670
• UDI-Public: (01)04546540711670(17)251015(10)23970144
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123377
• 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): 11/25/2024

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: 10/15/2025
• Device Catalogue Number: M0036154080
• Device Lot Number: 23970144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2022
• 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: SL-10 CATHETER (STRYKER); STENT (UNKNOWN); TARGET COILS (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female