MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 8MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035478300
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2022
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 treatment of posterior cerebral artery aneurysm the subject coil prematurely detached in the catheter and was removed using a snare.The subject device was replaced, and the procedure was completed successfully.There were no clinical consequences to the patient due to this event.
Event or Problem Description
It was reported that during the treatment of posterior cerebral artery aneurysm the subject coil prematurely detached in the catheter and was removed using a snare.The subject device was replaced, and the procedure was completed successfully.There were no clinical consequences to the patient due to this event.
Additional Manufacturer Narrative
The returned product was confirmed to be the product reported in the complaint.During visual inspection, the coil was found detached and kinked with delivery wire and introducer sheath not returned.The functional inspection could not be performed as the coil was returned detached.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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 device was returned for analysis and the reported event was confirmed.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information clarified that the device was prepared as per the dfu and that continuous flush was set up and maintained throughout the clinical procedure.The main coil was returned for analysis in the detached state and was also found to be kinked confirming the reported event.The coil delivery wire and introducer sheath were not returned for device analysis.This complaint appears to be associated with a product that met design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.Therefore, an assignable cause of procedural factors will be assigned to both as reported event main coil prematurely detached/separated during use and the as analyzed events main coil kinked/bent and main coil prematurely detached/separated during use.

• Brand Name: TARGET 360 SOFT 8MM X 30CM
• 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: 14981957
• Report Number: 3008881809-2022-00336
• Device Sequence Number: 20076982
• Product Code: HCG
• UDI-Device Identifier: 04546540676603
• UDI-Public: 04546540676603
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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): 10/24/2022

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: 03/28/2024
• Device Model Number: M0035478300
• Device Catalogue Number: M0035478300
• Device Lot Number: 22801353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2022
• Supplement Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2021
• 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: HEADWAY 27 MICROCATHETER (MICROVENTION); HEADWAY 27 MICROCATHETER (MICROVENTION); SOLITAIRE STENT RETRIEVER (MEDTRONIC); SOLITAIRE STENT RETRIEVER (MEDTRONIC)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown