MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 4.5MM X 12CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035474510
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the anterior communicating artery (acom artery) subarachnoid hemorrhage (sah) case, when subject coil was getting deployed into the aneurysm, it was found that a part of the subject coil got broken.When the subject coil was retrieved kink like shape was found between the first loop and the second loop of the subject coil.There were no clinical consequences to the patient reported as a result of this event and the procedure was completed successfully with another device.
Additional Manufacturer Narrative
G4 pma/510(k - corrected.D4 gtin - corrected.Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.The subject coil was not returned for analysis; therefore, physical as well as a functional testing could not be performed.The reported event is covered in the device direction 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 subject coil was not returned.Per the event description, the subject main coil was determined under fluoroscopy to be broken after insertion into the aneurysm.After removal it was observed that the subject coil was kinked between the first and second loops.However, as the subject coil has not been returned, it cannot be confirmed if the subject coil was actually broken.There were no anomalies noted to the device prior to use, and it appears to have been prepared per the dfu.The anatomy was noted to be severely tortuous which may have been a contributory factor.While there are a number of potential causes for the reported issues, because a review of available information failed to identify a definitive cause and the subject coil was not returned for analysis, an assignable cause of undeterminable was assigned to this complaint.
Event or Problem Description
It was reported that during the anterior communicating artery (acom artery) subarachnoid hemorrhage (sah) case, when subject coil was getting deployed into the aneurysm, it was found that a part of the subject coil got broken.When the subject coil was retrieved kink like shape was found between the first loop and the second loop of the subject coil.There were no clinical consequences to the patient reported as a result of this event and the procedure was completed successfully with another device.

• Brand Name: TARGET 360 SOFT 4.5MM X 12CM
• 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: 20306097
• Report Number: 3008881809-2024-00443
• Device Sequence Number: 7792107
• Product Code: HCG
• UDI-Device Identifier: 04546540714787
• UDI-Public: (01)04546540714787(17)241007(10)21795618R
• 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): 10/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/07/2024
• Device Catalogue Number: M0035474510
• Device Lot Number: 21795618R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2019
• 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: HEADWAY-17 (MICROVENTION)
• Patient Sex: Unknown