MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1.5MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035421530
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not yet received for evaluation.
Event or Problem Description
It was reported that during the procedure, the subject coil which had been previously detached and placed in the aneurysm successfully, became entangled with the second coil that was inserted into the aneurysm.When an attempt was made to re-position the second coil, it started jamming with the subject coil.The physician tried to pull out the second coil but it came out with the subject coil from inside the aneurysm back into the microcatheter.The procedure was reported as completed successfully with no clinical consequences to the patient due to this event.
Event or Problem Description
It was reported that during the procedure, the subject coil which had been previously detached and placed in the aneurysm successfully, became entangled with the second coil that was inserted into the aneurysm.When an attempt was made to re-position the second coil, it started jamming with the subject coil.The physician tried to pull out the second coil but it came out with the subject coil from inside the aneurysm back into the microcatheter.The procedure was reported as completed successfully with no clinical consequences 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.The device was received and reported lot number was confirmed from the packaging label.On visual/microscopic inspection, the main coil was returned with sl-10 microcatheter.The sl-10 was found to be intact.The main coil was found to be kinked/bent and stretched.The main coil was found to be detached.The coil seemed to be electrolytically detached.The coil delivery wire was not returned.Functional inspection was not required.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 available information indicates that the device was prepared as per the dfu, 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 main coil was returned for analysis and it was noted to have been kinked/bent and stretched.The reported event could not be confirmed however, the analysis results are consistent with the reported event.Therefore, an assignable cause of procedural factors will be assigned to the reported 'main coil migration' and 'device interaction with another device' and to the analyzed aa 'main coil stretched and main coil kinked/bent, as the 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.

• Brand Name: TARGET 360 NANO 1.5MM X 3CM
• 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: 12476248
• Report Number: 3008881809-2021-00379
• Device Sequence Number: 14425898
• Product Code: HCG
• UDI-Device Identifier: 04546540697943
• UDI-Public: 04546540697943
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 01/19/2022

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: 04/17/2024
• Device Model Number: M0035421530
• Device Catalogue Number: M0035421530
• Device Lot Number: 22850308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2021
• Supplement Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 01/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2021
• 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: COIL (UNKNOWN); MICROCATHETER (UNKNOWN); COIL (UNKNOWN); MICROCATHETER (UNKNOWN)
• Patient Sex: Unknown