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

Model Number	M0036127200
Medical Device Problem Codes	Fracture (1260); Expulsion (2933)
Health Effect - Clinical Codes	Stroke/CVA (1770); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Date of Event	07/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the subject coil was used during the coil embolization procedure for an aneurysm located at the anterior communicating artery (acom).After the first placement, a sling lying sub-optimally at the neck was noted due to the stretched subject coil, and the coil was pulled without a problem with 50-70% return.When reinserting the coil, a new sling was also noted, and the coil was retracted without feeling of resistance.At about 50% a crack was felt and the coil can no longer be controlled.The physician ten retracted the microcatheter with part of the coil.A completely distal nodule was noted on the coil and a snare device was used to capture and remove the coil.Imaging showed thrombi around the neck with the closure of one anterior branch due to the prolonged stay of the coil at this position.Integrilin was given to the patient, and the thrombus slowly dissolves after 20 minutes.Two small discrete infarcts in the anterior supply area were noted.No other information was provided at this time.
Additional Manufacturer Narrative
Section h - f10 / h6 medical device problem code - device code grid - expulsion removed.
Event or Problem Description
It was reported that the subject coil was used during the coil embolization procedure for an aneurysm located at the anterior communicating artery (acom).After the first placement, a sling lying sub-optimally at the neck was noted due to the stretched subject coil, and the coil was pulled without a problem with 50-70% return.When reinserting the coil, a new sling was also noted, and the coil was retracted without feeling of resistance.At about 50% a crack was felt and the coil can no longer be controlled.The physician ten retracted the microcatheter with part of the coil.A completely distal nodule was noted on the coil and a snare device was used to capture and remove the coil.Imaging showed thrombi around the neck with the closure of one anterior branch due to the prolonged stay of the coil at this position.Integrilin was given to the patient, and the thrombus slowly dissolves after 20 minutes.Two small discrete infarcts in the anterior supply area were noted.No other information was provided at this time.Additional information was received on 20-sep-2021 indicating that the patient luckily had no sequelae.
Additional Manufacturer Narrative
D4 expiration date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.H4 manufacturing date ¿ added.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the coil was returned stuck inside the microcatheter.The coil delivery wire was found to be kinked/bent in a few places.The main coil was found to be knotted.The main coil was found to be extremely stretched and the suture was found to be broken.The main coil was found to be broken/fractured.During functional testing, an attempt was made to remove the main coil from the microcatheter to confirm coil breakage.The catheter was cut in a few places as there was significant resistance.The main coil was then removed from the microcatheter and the coil breakage was confirmed.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.It was reported that the subject coil was placed, but a loop of the coil kept coming out of the aneurysm and lying sub-optimally at the neck; therefore, the coil was pulled back and reinserted.A new loop was also noted when trying to reinsert the coil again and a crack was felt when the physician tried to remove the coil out of the patient¿s anatomy.A snare device was used to remove the coil from the patient anatomy and the control injection showed thrombi around the neck with the closure of one anterior branch due to prolonged coil at this position during the procedure.Integrilin was given and the thrombus slowly dissolved after 20 mins.2 small discrete infarcts in the anterior supply area were noted at the end.Additional information provided by the customer indicated that no damage was noted to the device prior to use and initially there were no problems with the device in the initial introduction in the catheter or exiting the catheter, continuous flush was maintained, and the tortuosity of the patient's anatomy was average.An axs infinity long sheath 088 (stryker), sofia plus (microvention), excelsior sl-10 microcatheter (stryker), and sceptor xc balloon (microvention) were also used in the procedure.The device was returned stuck inside the sl-10 microcatheter.During analysis, the catheter was cut in a few places to remove the main coil and confirm the coil breakage.After removing the main coil, it was found to be broken/fractured and severely stretched with suture damage, confirming the reported event.The main coil was also found to be knotted and the coil delivery wire was found to be kinked/bent in several places.In the case of this complaint, it is likely that the coil was damaged during manipulation and attempted repositioning of the device during the procedure.An assignable cause of procedural factors was assigned to the as reported / as analyzed issues (excluding coil delivery wire kinked/bent) since these issues are associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural and/or anatomical factors during use.An assignable cause of handling damage was assigned to the as analyzed issue coil delivery wire kinked/bent' since this defect is associated with handling of the device during the clinical procedure.
Event or Problem Description
It was reported that the subject coil was used during the coil embolization procedure for an aneurysm located at the anterior communicating artery (acom).After the first placement, a sling lying sub-optimally at the neck was noted due to the stretched subject coil, and the coil was pulled without a problem with 50-70% return.When reinserting the coil, a new sling was also noted, and the coil was retracted without feeling of resistance.At about 50% a crack was felt and the coil can no longer be controlled.The physician ten retracted the microcatheter with part of the coil.A completely distal nodule was noted on the coil and a snare device was used to capture and remove the coil.Imaging showed thrombi around the neck with the closure of one anterior branch due to the prolonged stay of the coil at this position.Integrilin was given to the patient, and the thrombus slowly dissolves after 20 minutes.Two small discrete infarcts in the anterior supply area were noted.No other information was provided at this time.Additional information was received on 20-sep-2021 indicating that the patient luckily had no sequelae.

• 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: 12356489
• Report Number: 3008881809-2021-00343
• Device Sequence Number: 4815589
• Product Code: HCG
• UDI-Device Identifier: 07613327004632
• UDI-Public: 07613327004632
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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): 01/06/2022

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: 03/26/2024
• Device Model Number: M0036127200
• Device Catalogue Number: M0036127200
• Device Lot Number: 22817851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 09/20/2021; 12/09/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 10/06/2021; 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2021
• 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: AXS INFINITY LONG SHEATH 088 (STRYKER); EXCELSIOR SL10 MICROCATHETER (STRYKER); SCEPTOR XC BALLOON CATHETER (MICROVENTION); SOFIA¿ PLUS INTERMEDIATE CATHETERS (MICROVENTION)
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown