MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 3.5MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035443560
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device not returned.
Event or Problem Description
It was reported that during the procedure, the subject first coil was detached in the aneurysm; however, when the physician inserted a second coil, it was not able to advance the coil out of the microcatheter since to the proximal end of the first main coil was stuck inside the catheter tip.When the physician tried to pull back the catheter, the catheter dragged the first coil back in the vessel.A stent was deployed in the supraclinoid internal carotid artery (ica) to held down the coil tail in the vessel.90 minutes of surgical delay was reported.The patient was not affected as a result of this event.
Event or Problem Description
It was reported that during the procedure, the subject first coil was detached in the aneurysm; however, when the physician inserted a second coil, it was not able to advance the coil out of the microcatheter since to the proximal end of the first main coil was stuck inside the catheter tip.When the physician tried to pull back the catheter, the catheter dragged the first coil back in the vessel.A stent was deployed in the supraclinoid internal carotid artery (ica) to held down the coil tail in the vessel.90 minutes of surgical delay was reported.The patient was not affected as a result of 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 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.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, a cause of undeterminable was assigned to the as reported issues.

• Brand Name: TARGET 360 NANO 3.5MM X 6CM
• 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: 11074676
• Report Number: 3008881809-2020-00403
• Device Sequence Number: 3310824
• Product Code: HCG
• UDI-Device Identifier: 07613252600343
• UDI-Public: 07613252600343
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/16/2021

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 Expiration Date: 11/05/2021
• Device Model Number: M0035443560
• Device Catalogue Number: M0035443560
• Device Lot Number: 20976873
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/29/2020
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 02/16/2021
• 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: NEUROFORM ATLAS STENT (STRYLER); TARGET COIL (STRYKER)); XT-17 MICROCATHETER (STRYKER); NEUROFORM ATLAS STENT (STRYLER); TARGET COIL (STRYKER)); XT-17 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention