MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 4MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M0035474060

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/25/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : the device is not available for evaluation.

Event Description

It was reported during the coil embolization for an unruptured cerebral aneurysm in a-com (the anterior communicating artery), the subject coil was guided using with a stryker catheter, and while repositioning several times to engage with the vessel, a resistance was encountered.Fluoroscopic images showed that proximal of the subject coil seemed to be stretched, so it was operated more carefully and performed the detachment with the marker in the appropriate position, but the subject coil could not be detached.It was removed by the physician with a snare device.The subject coil was replaced, and the procedure was completed successfully with no clinical consequences to the patient.

Event Description

It was reported during the coil embolization for an unruptured cerebral aneurysm in a-com (the anterior communicating artery), the subject coil was guided using with a stryker catheter, and while repositioning several times to engage with the vessel, a resistance was encountered.Fluoroscopic images showed that proximal of the subject coil seemed to be stretched, so it was operated more carefully and performed the detachment with the marker in the appropriate position, but the subject coil could not be detached.It was removed by the physician with a snare device.The subject coil was replaced, and the procedure was completed successfully with no clinical consequences to the patient.

Manufacturer Narrative

H4 manufacturing date ¿ added.D4 expiration date - added.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 was not available; therefore, a visual inspection as well as a functional evaluation could not 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.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 was assigned to the reported event of main coil friction, main coil stretched, main coil failed/unable to detach, device difficulty engaging target vessel and patient medical or surgical intervention required.

• Brand Name: TARGET 360 SOFT 4MM X 6CM
• Type of Device: 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: 18097634
• MDR Text Key: 327698787
• Report Number: 3008881809-2023-00538
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 04546540676450
• UDI-Public: 04546540676450
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K153658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: M0035474060
• Device Lot Number: 23583755
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SL-10 CATHETER (STRYKER); SNARE (UNKNOWN)
• Patient Outcome(s): Required Intervention