MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 3MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number M0035423100

Device Problem Premature Separation (4045)

Patient Problem Obstruction/Occlusion (2422)

Event Date 02/13/2021

Event Type  Injury  

Manufacturer Narrative

The device is not available to the manufacturer.

Event Description

It was reported that during the procedure the physician used a micro catheter to deliver and deploy the subject coil as a second coil into the aneurysm in mca.While the physician was readjusting the subject coil in an attempt to have it better confirm to the aneurysm wall, it prematurely detached partially inside the aneurysm and partially in the parent vessel.A stent was used as a snare/additional device to tack up the tail of the subject coil which was in the parent vessel.It was reported that this attempt shut down the mca vessel and the procedure was completed without treating the occluded mca.A follow-up ct (computed tomography scan) was conducted post procedure and it was reported that the occlusion appeared to be open and was no longer occluded.It was reported that the patient is suffering from other co-morbidities unrelated to the procedure and subject device.According to physician, patient is doing well.No other clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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.Additional information provided by the customer indicated that no anomalies were noted to the device prior to use, the device was prepared as per the dfu, continuous flush was maintained for the duration of the procedure, the coil was not advanced or retracted with force, and the coil prematurely detached half in the aneurysm and half in the parent vessel (mca) while readjusting the coil to better conform to the aneurysm wall.It was noted that there was no allegation against the micro catheter and the stent was used to tack the coil.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 will be assigned to this complaint.

Event Description

It was reported that during the procedure the physician used a micro catheter to deliver and deploy the subject coil as a second coil into the aneurysm in mca.While the physician was readjusting the subject coil in an attempt to have it better confirm to the aneurysm wall, it prematurely detached partially inside the aneurysm and partially in the parent vessel.A stent was used as a snare/additional device to tack up the tail of the subject coil which was in the parent vessel.It was reported that this attempt shut down the mca vessel and the procedure was completed without treating the occluded mca.A follow-up ct (computed tomography scan) was conducted post procedure and it was reported that the occlusion appeared to be open and was no longer occluded.It was reported that the patient is suffering from other co-morbidities unrelated to the procedure and subject device.According to physician, patient is doing well.No other clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 ULTRA 3MM X 10CM
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 11507120
• MDR Text Key: 240427994
• Report Number: 3008881809-2021-00124
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 04546540675903
• UDI-Public: 04546540675903
• Combination Product (y/n): N
• PMA/PMN Number: K153658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2022
• Device Model Number: M0035423100
• Device Catalogue Number: M0035423100
• Device Lot Number: 21614414
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EXCELSIOR MICRO CATHETER (STRYKER); STENT (ENTERPRISE); EXCELSIOR MICRO CATHETER (STRYKER); STENT (ENTERPRISE)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 64 YR