MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 2.0MM X 3.5CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	TG5412035
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the treatment of a ruptured cerebral aneurysm, the subject coil was implanted as the first coil.Several attempts were made to detach it but it could not be detached.During retrieval of the subject coil, it got stretched and remained in the patient.The subject coil was successfully removed with a snare device.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Event or Problem Description
It was reported that during the treatment of a ruptured cerebral aneurysm, the subject coil was implanted as the first coil.Several attempts were made to detach it but it could not be detached.During retrieval of the subject coil, it got stretched and remained in the patient.The subject coil was successfully removed with a snare device.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
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 is not available; therefore, visual and functional testing as well as physical analysis cannot 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.It was reported that during the procedure the subject coil got stretched and a snare device was required to retrieve the coil.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared for use as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, a microcatheter was used in the procedure, the tapered distal end of the introducer sheath was firmly seated in the hub of the microcatheter, the rhv (rotating hemostatic valve) was adequately tightened while the introducer sheath was in the hub (not over/under-tightened) and was opened enough to allow passage of the device through without damage, no torque was given where advancing the delivery wire, the coil was advanced slowly and gently without applying excessive force, the rhv was sufficiently tightened prior to detachment, and no damage was sustained to the delivery wire during use.There were no allegations against the microcatheter and the detachment device.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, an assignable cause of undeterminable was assigned to the as reported events of main coil stretched, main coil failed/unable to detach, and patient medical or surgical intervention required.

• Brand Name: TARGET TETRA 2.0MM X 3.5CM
• 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: 19469061
• Report Number: 3008881809-2024-00254
• Device Sequence Number: 3418312
• Product Code: HCG
• UDI-Device Identifier: 07613327578584
• UDI-Public: 07613327578584
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K222533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2024

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 Expiration Date: 09/12/2026
• Device Catalogue Number: TG5412035
• Device Lot Number: 24493586
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/14/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INZONE POWER SUPPLY (STRYKER); SL-10 MICROCATHETER (STRYKER); SNARE DEVICE (UNKNOWN)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown