MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 6MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036126200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Thrombosis (2100); Foreign Body In Patient (2687)
Date of Event	05/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that during the procedure, when the physician tried to advance a coil (subject device), the coil got stuck around the struct of a stent.The physician tried to remove the coil from the subject stent but was not successful; therefore, two stents were deployed to fix the coil and the coil was detached.During the procedure, the patient developed thrombosis in the left p1.The physician tried remove the thrombus, but the procedure was ceased as the blood flow recovered.The patient is under additional treatment to treat the remaining blood clot in the p1.The patient is recovered and stable now.
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 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.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient, preparation/set-up was performed as per the dfu, and continuous flush was maintained for the duration of the procedure.In the physician's opinion, the coil got stuck around the strut of the stent due to a gap between the polypropylene tip and the coil itself that resulted from the welding coming off.While this may be a potential cause for the reported event, it cannot be definitively assessed since the device was not returned for analysis.Therefore, an assignable cause of undeterminable will be assigned to this complaint.
Event or Problem Description
It was reported that during the procedure, when the physician tried to advance a coil (subject device), the coil got stuck around the struct of a stent.The physician tried to remove the coil from the subject stent but was not successful; therefore, two stents were deployed to fix the coil and the coil was detached.During the procedure, the patient developed thrombosis in the left p1.The physician tried remove the thrombus, but the procedure was ceased as the blood flow recovered.The patient is under additional treatment to treat the remaining blood clot in the p1.The patient is recovered and stable now.

• Brand Name: TARGET XL 360 SOFT 6MM X 20CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 10156083
• Report Number: 3008881809-2020-00175
• Device Sequence Number: 2706442
• Product Code: HCG
• UDI-Device Identifier: 07613327004625
• UDI-Public: 07613327004625
• Combination Product (Y/N): N
• 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): 09/08/2020

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: 05/06/2022
• Device Model Number: M0036126200
• Device Catalogue Number: M0036126200
• Device Lot Number: 21396280
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/19/2020
• Supplement Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 06/15/2020
• Supplement Report FDA Received Date: 09/08/2020
• 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: ENTERPRISE STENT (CODMAN NEURO); ENTERPRISE STENT (NON-STRYKER); NEUROFORM ATLAS STENT (STRYKER); PHENOM 17 MICROCATHETER (MEDTRONIC); PHENOM 17 MICROCATHETER (MEDTRONIC); TARGET XL 360 SOFT COIL (STRYKER); ENTERPRISE STENT (NON-STRYKER); PHENOM 17 MICROCATHETER (MEDTRONIC); TARGET XL 360 SOFT COIL (STRYKER)
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention