MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 2MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035422040
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2021
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 during the mca m1 aneurysm procedure, physician used a guide catheter to bring the guide wire into the ica, exchanged the guide wire and brought the micro catheter to the aneurysm.The coil was delivered into the aneurysm but it could not be framed properly, so a stent was deployed to support the coil inside the aneurysm.Several coils were filled in the aneurysm.Then the subject coil was prepared to fill but the physician could not push it completely into the aneurysm.He decided to withdraw the subject coil, and it was found fractured.Physician retracted the micro catheter with the subject coil but it was left inside the vessel.So, he deployed a stent to cover the subject coil but still it wasn't covered completely.He decide to place another stent but it was difficult to advance and got stuck at the hub of the micro catheter.It was replaced with another stent was successfully deployed.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.D4 expiration date - added.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 as well as physical analysis cannot be performed.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.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 and the device was not returned, an assignable cause of undeterminable will be assigned to this complaint.
Event or Problem Description
It was reported that during the mca m1 aneurysm procedure, physician used a guide catheter to bring the guide wire into the ica, exchanged the guide wire and brought the micro catheter to the aneurysm.The coil was delivered into the aneurysm but it could not be framed properly, so a stent was deployed to support the coil inside the aneurysm.Several coils were filled in the aneurysm.Then the subject coil was prepared to fill but the physician could not push it completely into the aneurysm.He decided to withdraw the subject coil, and it was found fractured.Physician retracted the micro catheter with the subject coil but it was left inside the vessel.So, he deployed a stent to cover the subject coil but still it wasn't covered completely.He decide to place another stent but it was difficult to advance and got stuck at the hub of the micro catheter.It was replaced with another stent was successfully deployed.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: TARGET 360 ULTRA 2MM X 4CM
• 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: 12054478
• Report Number: 3008881809-2021-00272
• Device Sequence Number: 3469353
• Product Code: HCG
• UDI-Device Identifier: 04546540675842
• UDI-Public: 04546540675842
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 09/08/2021

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: 11/25/2023
• Device Model Number: M0035422040
• Device Catalogue Number: M0035422040
• Device Lot Number: 22603209
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/31/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 09/08/2021
• 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: EXCELSIOR SL-10 MICRO CATHETER (STRYKER); EXCELSIOR XT-27 MICRO CATHETER (STRYKER); GUIDE CATHETER (UNKNOWN); NEUROFORM EZ STENT (STRYKER); SLIM GUIDE WIRE (UNKNOWN); SYNCHRO GUIDE WIRE (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR