MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 STANDARD 15 MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035461540
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that cerebral coiling procedure was performed to treat caroticocavernous fistula in a patient.The subject coil was the third coil used in the procedure.During the procedure the subject coil was advanced through a microcatheter without any resistance.Before detachment of the subject coil the physician checked for the position of the subject coil and noticed that part of the subject coil was within the middle of the cerebral artery.Therefore the physician decided to slowly retrieve, readjust and redeploy the subject coil within the target lesion.During this attempt of redeployment the physician noticed that the last few centimeters of the subject coil was not responding to any push or pull motion.The physician decided to retrieve the subject coil and noticed it had been detached.The physician then removed the subject coil along with the microcatheter out of the patient's vasculature.The subject coil was replaced and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H3 summary attached - updated h3 device evaluated by mfg ¿updated h4 manufacturing date ¿ added d4 expiration date - added due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual/microscopic inspection: the device was returned together with a microcatheter.The microcatheter was found to be intact.The coil delivery was found to be kinked/bent.The main coil was found to be broken/fractured.There was no detachment noted.The detachment zone was found to be intact.The coil introducer sheath was not returned.Functional inspection: main coil friction functional test ¿ unable to performed as the coil was found to be broken/fractured.Main coil prematurely detached/separated during use ¿ not confirmed during visuals.The coil was found to be broken/fractured not detached.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 main coil friction could not be confirmed; however, the analysis results are consistent with the reported event.The reported main coil prematurely detached/separated during use was not confirmed during analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.During analysis, the main coil was found to be broken/fractured and the coil delivery wire was found to be kinked/bent.An assignable cause of procedural factors will be assigned to the as analyzed 'main coil broken/fractured during use', and the as reported 'main coil friction', as these issues appear to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.An assignable cause of not confirmed will be assigned to the as reported 'main coil prematurely detached/separated during use', as the defect was not confirmed during the analysis.An assignable cause of handling damage will be assigned to the as analyzed 'coil delivery wire kinked/bent' since this issue is associated with handling of the device during the clinical procedure.
Event or Problem Description
It was reported that cerebral coiling procedure was performed to treat caroticocavernous fistula in a patient.The subject coil was the third coil used in the procedure.During the procedure the subject coil was advanced through a microcatheter without any resistance.Before detachment of the subject coil the physician checked for the position of the subject coil and noticed that part of the subject coil was within the middle of the cerebral artery.Therefore the physician decided to slowly retrieve, readjust and redeploy the subject coil within the target lesion.During this attempt of redeployment the physician noticed that the last few centimeters of the subject coil was not responding to any push or pull motion.The physician decided to retrieve the subject coil and noticed it had been detached.The physician then removed the subject coil along with the microcatheter out of the patient's vasculature.The subject coil was replaced and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 STANDARD 15 MM X 40CM
• 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: 14757476
• Report Number: 3008881809-2022-00304
• Device Sequence Number: 12267730
• Product Code: HCG
• UDI-Device Identifier: 07613252192534
• UDI-Public: 07613252192534
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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): 08/12/2022

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: 11/26/2022
• Device Model Number: M0035461540
• Device Catalogue Number: M0035461540
• Device Lot Number: 21938477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/26/2022
• Supplement Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2019
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER)
• Patient Sex: Female