MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 7MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036127200
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the coil embolization procedure of an unruptured aneurysm in the anterior communicating artery, a stent was implanted using the trans cell technique and a microcatheter was placed in the aneurysm.Embolization was started with the subject coil as the framing coil.For the repositioning of the subject coil to engage with the aneurysm, the delivery wire was retracted to pull the subject coil back to the microcatheter.While about two loops of the subject coil were out of the microcatheter, it was found that the subject coil was not seen under the fluoroscopy.When the delivery wire of the subject coil was pulled carefully, it was found that the subject coil was prematurely detached.The entire microcatheter was removed from the body, and the prematurely detached subject coil was removed out of the microcatheter.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 manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.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 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.Per the event description the main coil detached inside the microcatheter during repositioning.There were no anomalies noted to the device prior to use and appears to have been prepared per the dfu.While there are a number of potential causes for the reported issues, because a review of available information failed to identify a definitive cause and the device was not returned for analysis, an assignable cause of undeterminable was assigned to this complaint.
Event or Problem Description
It was reported that during the coil embolization procedure of an unruptured aneurysm in the anterior communicating artery, a stent was implanted using the trans cell technique and a microcatheter was placed in the aneurysm.Embolization was started with the subject coil as the framing coil.For the repositioning of the subject coil to engage with the aneurysm, the delivery wire was retracted to pull the subject coil back to the microcatheter.While about two loops of the subject coil were out of the microcatheter, it was found that the subject coil was not seen under the fluoroscopy.When the delivery wire of the subject coil was pulled carefully, it was found that the subject coil was prematurely detached.The entire microcatheter was removed from the body, and the prematurely detached subject coil was removed out of the microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: TARGET XL 360 SOFT 7MM 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: 20191726
• Report Number: 3008881809-2024-00417
• Device Sequence Number: 6792631
• Product Code: HCG
• UDI-Device Identifier: 07613327004632
• UDI-Public: (01)07613327004632(17)261125(10)24633124
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123377
• 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): 10/21/2024

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 Catalogue Number: M0036127200
• Device Lot Number: 24633124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/27/2023
• 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: NEUROFORM ATLAS STENT (STRYKER).; SL-10 MICROCATHETER (STRYKER).
• Patient Age: 74 YR
• Patient Sex: Female