MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 1MM X 2CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035431020
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	10/07/2021
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 physician detached the subject coil into the aneurysm.On withdraw the microcatheter, the subject coil was found stuck at the distal tip of the microcatheter and protrude into the parent vessel.The physician deployed stent as medical intervention to secure the coil mass.However, a thrombus was generated so tirofiban half ample is given to the patient.The procedure was completed successfully, and no other information was available.
Additional Manufacturer Narrative
D4 expiration date - added.H4 manufacturing date ¿ added.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.No visual or functional inspection was performed due to product was 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.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, a cause of 'undeterminable' was assigned to the as reported cause 'main coil protrusion' and 'coil jammed'.The as reported 'patient vessel thrombosis' is a known and anticipated complication to these types of procedures and patient condition and is listed as such in the device directions for use.Therefore, a probable cause of 'anticipated procedural complication' was assigned to this event.
Event or Problem Description
It was reported that during the procedure, the physician detached the subject coil into the aneurysm.On withdraw the microcatheter, the subject coil was found stuck at the distal tip of the microcatheter and protrude into the parent vessel.The physician deployed stent as medical intervention to secure the coil mass.However, a thrombus was generated so tirofiban half ample is given to the patient.The procedure was completed successfully, and no other information was available.

• Brand Name: TARGET HELICAL NANO 1MM X 2CM
• 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: 12716825
• Report Number: 3008881809-2021-00453
• Device Sequence Number: 4103335
• Product Code: HCG
• UDI-Device Identifier: 04546540698001
• UDI-Public: 04546540698001
• 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): 02/25/2022

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: 01/19/2024
• Device Model Number: M0035431020
• Device Catalogue Number: M0035431020
• Device Lot Number: 22662890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/10/2021
• Supplement Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2021
• 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: NEUROFORM ATLAS STENT (STRYKER); SL-10 MICROCATHETER (STRYKER); SYNCHOR 14 GUIDEWIRE (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown