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

Model Number	M0036126200
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2021
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 a procedure of coiling a brain aneurysm, when the physician was advancing the subject coil, it prematurely detached in the microcatheter.The physician removed the subject microcatheter and used a snare and completed the procedure successfully and no clinical consequences were reported due to this event.
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 main coil was found to be detached from the delivery wire and only delivery wire was returned, and the coil delivery wire was found to be kinked/bent.Functional test was unable to perform.The reported complaint was confirmed based on analysis.The analysis results are consistent with the event.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.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 there was no damage noted to the packaging prior to opening, the device was confirmed to be in good condition during preparation/prior to use on the patient and continuous flush was set up and maintained during the clinical procedure.The excelsior sl-10 microcatheter was undamaged and the physician was unsure of the anatomical location where the issue occurred.However, the anatomy was described as slightly tortuous.There was no attempt to detach the coil using an inzone device.Based on the investigation, this complaint appears to be 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.Therefore, an assignable cause of procedural factors will be assigned to the 'main coil prematurely separated/detached during use'.An assignable cause of handling damage will be assigned to the ¿coil delivery wire kinked/bent' as it is most likely that the delivery wire damage occurred due to handling of the device during use.
Event or Problem Description
It was reported that during a procedure of coiling a brain aneurysm, when the physician was advancing the subject coil, it prematurely detached in the microcatheter.The physician removed the subject microcatheter and used a snare and completed the procedure successfully and no clinical consequences were reported due to this event.

• 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 ; EI NA
• MDR Report Key: 12105705
• Report Number: 3008881809-2021-00289
• Device Sequence Number: 14396562
• Product Code: HCG
• UDI-Device Identifier: 07613327004625
• UDI-Public: 07613327004625
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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): 09/23/2021

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: 11/03/2023
• Device Model Number: M0036126200
• Device Catalogue Number: M0036126200
• Device Lot Number: 22555384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Initial Date Received by Manufacturer: 06/18/2021
• Supplement Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 07/02/2021
• Supplement Report FDA Received Date: 09/23/2021
• 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 (STRYKER MANUFACTURER); EXCELSIOR SL-10 (STRYKER MANUFACTURER)
• Outcome Attributed to Adverse Event: Required Intervention