MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 3MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number M0035473080

Device Problems Fracture (1260); Migration (4003)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/11/2022

Event Type  Injury  

Event Description

It was reported that neuro endovascular coil embolization procedure was planned for right posterior communicating artery aneurysm.It was reported that during the procedure physician deployed few coils inside the aneurysm.First attempt of coiling with the subject coil was unsuccessful, so physician removed and re-sheathed it and load the same coil after repositioning the micro catheter.After repositioning subject coil inside the aneurysm before detachment attempt was made with detachment system, the subject coil abnormally streaked in its more distal part and then broke off in the micro catheter in its more proximal part.Subject coil could not be removed with a lasso, and stent was required to plate the floating portion of the subject coil against the artery wall at the carotid termination.Because of the reported issue, partial endovascular treatment of the aneurysm along with spiral overflow opposite the posterior communicating artery were noted and double antiplatelet aggregation treatment was also required.Patient received aspegic iv + cangrelor iv per procedure.Patient will be receiving kardegic and brilique 3 months and then kardegic for 6 months.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

The device is not available to the manufacturer.

Manufacturer Narrative

Due to the automated 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 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.Additional information provided by the customer was after a few coils were deployed, the subject coil abnormally streaked in its more distal part and then broke off in the micro catheter in its more proximal part.The coil remained in the patient's artery because it could not be removed with a lasso.It was then a requirement to stent the patient to plate the floating portion of the coil against the artery wall.And the patient had to put under a double anti aggregation treatment.It was also reported the device was prepared as per the dfu, that there was no damage noted to the packaging prior to opening and the device was confirmed to be in good condition during preparation/prior to use on the patient, and that continuous flush was set up and maintained during the procedure.While there are a number of potential causes for the reported issue of main coil broken/fractured use and main coil migration, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned.

Event Description

It was reported that neuro endovascular coil embolization procedure was planned for right posterior communicating artery aneurysm.It was reported that during the procedure physician deployed few coils inside the aneurysm.First attempt of coiling with the subject coil was unsuccessful, so physician removed and re-sheathed it and load the same coil after repositioning the micro catheter.After repositioning subject coil inside the aneurysm before detachment attempt was made with detachment system, the subject coil abnormally streaked in its more distal part and then broke off in the micro catheter in its more proximal part.Subject coil could not be removed with a lasso, and stent was required to plate the floating portion of the subject coil against the artery wall at the carotid termination.Because of the reported issue, partial endovascular treatment of the aneurysm along with spiral overflow opposite the posterior communicating artery were noted and double antiplatelet aggregation treatment was also required.Patient received aspegic iv + cangrelor iv per procedure.Patient will be receiving kardegic and brilique 3 months and then kardegic for 6 months.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 SOFT 3MM X 8CM
• 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: 14196650
• MDR Text Key: 290962952
• Report Number: 3008881809-2022-00192
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 04546540676436
• UDI-Public: 04546540676436
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K153658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/12/2022

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
• Device Operator: Health Professional
• Device Model Number: M0035473080
• Device Catalogue Number: M0035473080
• Device Lot Number: 23443300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2022
• Initial Date FDA Received: 04/25/2022
• Supplement Dates Manufacturer Received: 06/23/2022
• Supplement Dates FDA Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2022
• 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: ECHELON 14 MICROCATHETER (MEDTRONIC); NEURON 6F INTRACRANIAL ACCESS SYSTEM (PENUMBRA); TARGET 360SOFT COILS (STRYKER)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 60 KG