MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 3MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035423100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during a aneurysm embolization case, when the operator tried to withdraw the subject coil, the subject coil encountered resistance as the subject coil got tangled with other coils present in the aneurysm.While doing so the coil stretched and fractured during the procedure.The operator used a stent to remove the stretched and fractured part of the subject coil and deployed the same stent to cover the rest of the subject coil to the vessel wall and finished the procedure.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.On visual/microscopic inspection, it was noted that the delivery wire was kinked/bent.The main coil was found to be extremely stretched and broken/fractured.The proximal contact was broken fractured.Functional inspection was unable to perform due to condition of device.Proximal contact 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.The reported complaint was confirmed during device analysis.The device failed to meet specifications when received for complaint investigation based on damage noted to the device during the analysis.Additional information provided by the customer indicated that the device prepared for use as per the directions for use, there was no damage noted to the packaging prior to opening the packaging, the device was confirmed to be in good condition during preparation/prior to use on the patient and continuous flush was set up and maintained throughout the clinical procedure.The device was returned for analysis and the coil delivery wire was noted to be kinked/bent.The main coil was returned stretched and broken/fractured.The proximal contact was completely broken and not returned making it impossible to do a functional test.An assignable cause of procedural factors will be assigned to the as reported 'device interaction with another device, main coil stretch, proximal contact broken/fractured, main coil broken/fractured during use and main coil failed/unable to detach., as these defects appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.The as analyzed 'coil delivery wire kinked/bent' will be assigned procedural factors as this issue is associated with a product that meets stryker design and manufacture specifications and was used in according 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 during a aneurysm embolization case, when the operator tried to withdraw the subject coil, the subject coil encountered resistance as the subject coil got tangled with other coils present in the aneurysm.While doing so the coil stretched and fractured during the procedure.The operator used a stent to remove the stretched and fractured part of the subject coil and deployed the same stent to cover the rest of the subject coil to the vessel wall and finished the procedure.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 ULTRA 3MM X 10CM
• 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: 16301684
• Report Number: 3008881809-2023-00059
• Device Sequence Number: 6165943
• Product Code: HCG
• UDI-Device Identifier: 04546540675903
• UDI-Public: 04546540675903
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 04/25/2023

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: 03/12/2025
• Device Model Number: M0035423100
• Device Catalogue Number: M0035423100
• Device Lot Number: 23534278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/15/2023
• Supplement Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 02/04/2023
• Supplement Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Race: Asian