MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 3MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035443060
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	06/20/2021
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 the procedure, the mca aneurysm was re-ruptured after clipping and physician switched to coil embolization.A microcatheter was used to reach the target site and 11 coils were filled in the aneurysm before the subject coil.While using the subject coil physician found it difficult to insert it into the microcatheter but was able to advance it to the aneurysm.While reaching middle of the aneurysm the subject coil got stretched and a snare device was used to retrieve the subject coil.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 mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The product was not returned for investigation.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.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 as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, the tortuosity of the patient's anatomy was normal, the tapered distal end of the introducer sheath was firmly seated in the hub of the microcatheter, the rhv was adequately tightened while the introducer sheath was in the hub (not over/under-tightened), the coil was advanced slowly and gently without applying excessive force, and no torque was given where advancing the delivery wire.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 and the device was not returned, an assignable cause of undeterminable will be assigned to this complaint.
Event or Problem Description
It was reported that during the procedure, the mca aneurysm was re-ruptured after clipping and physician switched to coil embolization.A microcatheter was used to reach the target site and 11 coils were filled in the aneurysm before the subject coil.While using the subject coil physician found it difficult to insert it into the microcatheter but was able to advance it to the aneurysm.While reaching middle of the aneurysm the subject coil got stretched and a snare device was used to retrieve the subject coil.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: TARGET 360 NANO 3MM X 6CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 12176352
• Report Number: 3008881809-2021-00301
• Device Sequence Number: 13674958
• Product Code: HCG
• UDI-Device Identifier: 07613252600329
• UDI-Public: 07613252600329
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 10/11/2021

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: 01/04/2024
• Device Model Number: M0035443060
• Device Catalogue Number: M0035443060
• Device Lot Number: 22655306
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 10/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COILS (UNKNOWN); GOOSENECK SNARE (UNKNOWN); PHENOM MICROCATHETER (MEDTRONICS); COILS (UNKNOWN); GOOSENECK SNARE (UNKNOWN); PHENOM MICROCATHETER (MEDTRONICS)
• Outcome Attributed to Adverse Event: Required Intervention