MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 7MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036127200
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Vasoconstriction (2126)
Date of Event	03/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is 1 of 2 reports (1st mdr).The device is not available to the manufacturer.
Event or Problem Description
It was reported that during coil embolization of an aneurysm at the bifurcation of the ophthalmic artery, sl-10 and headway 17 microcatheters were placed in the aneurysm, and atlas stent was placed for coil embolization using the jail method.When the coil (subject device) was inserted as the first coil, the sl-10 microcatheter was kicked back out of the aneurysm.While retracting the coil (subject device), there was a feeling of being stuck in the atlas due to strong resistance.When the coil (subject device) was slowly retracted, the detachment part was detached.Thus, the microcatheter was retracted slowly, the coil (subject device) has also come along with the microcatheter, then it happened to drag and migrate the atlas stent.A gooseneck used as a medical intervention to retrieve the coil (subject device).At that time, because the coil (subject device) was entangled in the strut of the atlas, the atlas was retrieved together with the coil (subject device), and the coil (subject device) was removed in the guide catheter (optimo 9fr).There was some spasm, which may have been caused by the stimulation of stent removal, but it resolved with time.A ct scan was done immediately after the procedure and showed no bleeding.The procedure was completed successfully.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added h3 device evaluated by mfg ¿updated h3 summary attached - updated d4 expiration date - added d9 product available to stryker ¿ updated d9 returned to manufacturer on ¿updated.Due to the automated mes (manufacturing execution system) system, there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the coil delivery wire was found to be kinked/bent, the coil delivery wire was found to be physically detached from the main coil and the main coil was not returned.A functional test for the reported event main coil prematurely detached/separated inside patient was confirmed as the delivery wire was confirmed to be physically detached from the main coil.A functional test for device interaction with another device, main coil tangled, patient vasospasm non-serious, and main coil stretched was not available.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.The reported 'main coil prematurely detached/separated during use', was confirmed during analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that the subject coil was inserted as the first coil, but the microcatheter was kicked back out of the aneurysm, so the subject coil was retracted.While retracting the subject coil, there was feeling of stuck in the stent due to strong resistance.Since the microcatheter could not be reinserted, when the subject coil was slowly retracted, the detachment part was detached.Thus, the microcatheter was retracted slowly, the subject coil was also come along with the microcatheter, then it happened to drag and migrate the stent.At the result, the subject coil was completely out of the microcatheter (left inside of the body).Then used a gooseneck snare to retrieve the coil.Analysis of the returned device revealed the coil delivery wire was kinked/bent and the main coil had been prematurely detached/separated from the delivery wire, therefore, the as reported ¿main coil prematurely detached/separated during use' was confirmed.The reported 'device interaction with another device' and 'patient vasospasm non-serious' could not be confirmed as the events are patient/procedure related.The reported 'main coil tangled' and 'main coil stretched' could not be confirmed as the main coil was not returned for analysis.The analysis results are consistent with the reported events.It is probable that the main coil microcatheter kick back caused the main coil to become tangled within the struts of the stent, and the main coil was subsequently stretched and prematurely detached during the attempt to remove the microcatheter and coil.An assignable cause of caused by other will be assigned to the reported and analyzed ¿main coil prematurely detached/separated during use' and to the reported 'device interaction with another device', 'main coil tangled'.'patient vasospasm non-serious', and 'main coil stretched¿ as the investigation indicates another product(s) caused the issue event.It is probable that the delivery wire proximal end was kinked due to handling of the device during use, therefore an assignable cause of handling damage will be assigned to the analyzed 'coil delivery wire kinked/bent'.
Event or Problem Description
It was reported that during coil embolization of an aneurysm at the bifurcation of the ophthalmic artery, sl-10 and headway 17 microcatheters were placed in the aneurysm, and atlas stent was placed for coil embolization using the jail method.When the coil (subject device) was inserted as the first coil, the sl-10 microcatheter was kicked back out of the aneurysm.While retracting the coil (subject device), there was a feeling of being stuck in the atlas due to strong resistance.When the coil (subject device) was slowly retracted, the detachment part was detached.Thus, the microcatheter was retracted slowly, the coil (subject device) has also come along with the microcatheter, then it happened to drag and migrate the atlas stent.A gooseneck used as a medical intervention to retrieve the coil (subject device).At that time, because the coil (subject device) was entangled in the strut of the atlas, the atlas was retrieved together with the coil (subject device), and the coil (subject device) was removed in the guide catheter (optimo 9fr).There was some spasm, which may have been caused by the stimulation of stent removal, but it resolved with time.A ct scan was done immediately after the procedure and showed no bleeding.The procedure was completed successfully.

• Brand Name: TARGET XL 360 SOFT 7MM X 20CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 13879095
• Report Number: 3008881809-2022-00136
• Device Sequence Number: 5264307
• Product Code: HCG
• UDI-Device Identifier: 07613327004632
• UDI-Public: 07613327004632
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/10/2022

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: 07/17/2024
• Device Model Number: M0036127200
• Device Catalogue Number: M0036127200
• Device Lot Number: 23043497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2022
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATLAS STENT (STRYKER); HEADWAY MICROCATHETER (NON-STRYKER); OPTIMO 9FR GUIDE CATHETER (NON-STRYKER); SL-10 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown