MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 STANDARD 12MM X 45CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036101240
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that for treating a large unruptured m2 bifurcation aneurysm physician used the subject coil (target coil) as the sixth coil for filling.During this attempt, the physician felt resistance and decided to remove the subject coil.Resistance continued while removing the subject coil from the aneurysm and its mid-section started stretching.The physician made several attempts to snare the subject coil and withdraw it from the patient¿s anatomy but all of the attempts were unsuccessful.The subject coil got fractured during the removal attempt due to which the stretched part of the subject coil came off the aneurysm and got into the m2 segment down to the common carotid artery.The physician deployed a stent as a snare device and placed in the m1 segment to tack the stretched portion of the subject coil.It was reported that the procedure was not completed and as per the physician, no additional surgery is planned.No additional clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that for treating a large unruptured m2 bifurcation aneurysm physician used the subject coil (target coil) as the sixth coil for filling.During this attempt, the physician felt resistance and decided to remove the subject coil.Resistance continued while removing the subject coil from the aneurysm and its mid-section started stretching.The physician made several attempts to snare the subject coil and withdraw it from the patient¿s anatomy but all of the attempts were unsuccessful.The subject coil got fractured during the removal attempt due to which the stretched part of the subject coil came off the aneurysm and got into the m2 segment down to the common carotid artery.The physician deployed a stent as a snare device and placed in the m1 segment to tack the stretched portion of the subject coil.It was reported that the procedure was not completed and as per the physician, no additional surgery is planned.No additional clinical consequences were reported to the patient due to this event.
Additional 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 the device was prepared for use as per the directions for use and continuous flush set up and maintained throughout the clinical procedure.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.

• Brand Name: TARGET XL 360 STANDARD 12MM X 45CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 11816188
• Report Number: 3008881809-2021-00195
• Device Sequence Number: 3792416
• Product Code: HCG
• UDI-Device Identifier: 04546540711281
• UDI-Public: 04546540711281
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K153658
• 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): 07/14/2021

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
• Operator of Device: Health Professional
• Device Model Number: M0036101240
• Device Catalogue Number: M0036101240
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ECHELON MICRO CATHETER (MEDTRONICS); NEUROFORM STENT (STRYKER); TARGET COILS (STRYKER); ECHELON MICRO CATHETER (MEDTRONICS); NEUROFORM STENT (STRYKER); TARGET COILS (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention