MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 8MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036180820
Medical Device Problem Codes	Expulsion (2933); Premature Separation (4045)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during stent assisted coil embolization case, physician tried to re-sheath the subject coil.When it was pulled back to remove, the subject coil was found to be stretched and had prematurely detached inside the patient.It was not attempted to remove the subject coil.There is no immediate patient consequence.No further information is available.
Additional Manufacturer Narrative
H3 other text : the device remains inside the patient.
Event or Problem Description
It was reported that during stent assisted coil embolization case, physician tried to re-sheath the subject coil.When it was pulled back to remove, the subject coil was found to be stretched and had prematurely detached inside the patient.It was not attempted to remove the subject coil.There is no immediate patient consequence.No further information is available.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.D4 expiration date - added.F10 / h6 health effect - clinical code - updated.Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.The subject coil was not returned for analysis; therefore, physical as well as a functional testing could not be performed.The reported event is covered in the device direction 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 complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Additional information provided by the customer indicated that the subject coil was not advanced or retracted with force, there was no allegation against the detachment system or the microcatheter used in the procedure, continuous flush was maintained, the anatomy was not tortuous, the location of the treatment site was at the basilar tip, there was no friction felt during the procedure, the subject coil was re-sheathed during the procedure because it was not behaving as needed, the issue occurred with the last coil used in the case, and the premature detachment was noticed upon removal from the body when the physician realized there was no subject coil attached to the pusher wire.While there are a number of potential causes for the reported issue, because review of available information failed to identify a definitive cause and the subject coil was not returned for analysis, an assignable cause of undeterminable was assigned to this complaint.
Additional Manufacturer Narrative
B5 executive summary - updated due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.The subject coil was not returned for analysis; therefore, physical as well as a functional testing could not be performed.The reported event is covered in the device direction 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 complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.It was reported that during the procedure (stent assisted coil embolization), the subject coil prematurely detached during use and was left in the patient's body.The stretched component of the subject coil was seen protruding from the aneurysm.Additional information provided by the customer indicated that the coil was not advanced or retracted with force, there was no allegation against the detachment system or the microcatheter used in the procedure, continuous flush was maintained, the anatomy was not tortuous, the location of the treatment site was at the basilar tip, there was no friction felt during the procedure, the coil was re-sheathed during the procedure because it was not behaving as needed, the issue occurred with the last coil used in the case, and the premature detachment was noticed upon removal from the body when the physician realized there was no coil attached to the pusher wire.While there are a number of potential causes for the reported issue, because review of available information failed to identify a definitive cause and the subject coil was not returned for analysis, an assignable cause of undeterminable was assigned to this complaint.
Event or Problem Description
It was reported that during stent assisted coil embolization case, physician tried to re-sheath the subject coil.When it was pulled back to remove, the subject coil was found to be stretched and had prematurely detached inside the patient.It was not attempted to remove the subject coil.There is no immediate patient consequence.No further information is available.Update: the stretched component of subject coil was both in the aneurysm and outside, continuing down to proximal vessels.

• Brand Name: TARGET XXL 360 8MM X 20CM
• 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: 19211662
• Report Number: 3008881809-2024-00184
• Device Sequence Number: 12785300
• Product Code: HCG
• UDI-Device Identifier: 07613327466416
• UDI-Public: 07613327466416
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K161429
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/08/2024

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: 10/02/2026
• Device Catalogue Number: M0036180820
• Device Lot Number: 2456363
• 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: 04/08/2024
• Supplement Date Received by Manufacturer: 05/28/2024; 06/20/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 06/17/2024; 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2023
• 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 1018 MICROCATHETER (STRYKER)
• Patient Sex: Unknown