MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 STANDARD 16MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036101650
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that during the procedure, the physician encountered resistance while pulling back the subject coil from inside the micro catheter.The physician felt that the coil was oversized inside the aneurysm and protruding into parent vessel.The subject coil was successfully removed from the patient's anatomy.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 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.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.As per the available information the coil was protruding into the parent vessel because it was oversized.It is probable that the main coil protruded into the parent vessel due to being incorrectly sized for the aneurysm and the subsequent difficulty to remove the coil through the microcatheter.An assignable cause of user error will be assigned to the reported coil difficult to remove/withdraw from catheter, main coil protrusion and user preference issue, as the issue investigation confirms that there was an act or omission of an act that resulted in a different medical product response than intended by the manufacturer and/or expected by the user.
Event or Problem Description
It was reported that during the procedure, the physician encountered resistance while pulling back the subject coil from inside the micro catheter.The physician felt that the coil was oversized inside the aneurysm and protruding into parent vessel.The subject coil was successfully removed from the patient's anatomy.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes), there are controls in the manufacturing process to ensure the product met specifications upon release.The device was received and the reported lot number was confirmed from the packaging label.On visual/microscopic inspection, the coil delivery wire was noted to be kinked/bent.Congealed blood was noted in the introducer sheath and on the delivery wire.Dimensional inspection could not be completed as the delivery wire could not be advanced through or retracted out of the introducer sheath.Functional inspection could not be completed as the delivery wire could not be advanced through or retracted out of the introducer sheath.The reported event was not confirmed during analysis, however the analysis results are consistent with the event.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.As per the available information, the coil was protruding into the parent vessel because it was oversized.The device was returned and found to be stuck within the introducer sheath due to congealed blood within, and was not able to be removed.It is probable that the main coil protruded into the parent vessel due to being incorrectly sized for the aneurysm and the subsequent difficulty to remove the coil through the microcatheter.An assignable cause of user error will be assigned to the reported coil difficult to remove/withdraw from catheter, main coil protrusion and user preference issue, and the analyzed coil introducer sheath friction, as the issue investigation confirms that there was an act or omission of an act that resulted in a different medical product response than intended by the manufacturer and/or expected by the user.An assignable cause of handling damage will be assigned to the analyzed coil delivery wire kinked/bent as it is probable that this occurred due to handling of the device.
Event or Problem Description
It was reported that during the procedure, the physician encountered resistance while pulling back the subject coil from inside the micro catheter.The physician felt that the coil was oversized inside the aneurysm and protruding into parent vessel.The subject coil was successfully removed from the patient's anatomy.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: TARGET XL 360 STANDARD 16MM X 50CM
• 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: 11290082
• Report Number: 3008881809-2021-00068
• Device Sequence Number: 17213292
• Product Code: HCG
• UDI-Device Identifier: 04546540711304
• UDI-Public: 04546540711304
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup
• Report Date (Section B): 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/25/2023
• Device Model Number: M0036101650
• Device Catalogue Number: M0036101650
• Device Lot Number: 22285631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Initial Date Received by Manufacturer: 01/15/2021
• Supplement Date Received by Manufacturer: 03/11/2021; 06/18/2021
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 04/05/2021; 06/29/2021
• 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)
• Patient Age: 40 YR