MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 3MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035443060
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the proximal section of the coil (subject device) stretched and prematurely detached inside the micro catheter while embolizing an unruptured cerebral aneurysm.The subject device was replaced and the procedure was completed successfully.There were no clinical consequences to the patient due to this event.
Event or Problem Description
It was reported that the proximal section of the coil (subject device) stretched and prematurely detached inside the micro catheter while embolizing an unruptured cerebral aneurysm.The subject device was replaced and the procedure was completed successfully.There were no clinical consequences to the patient 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 the device was returned and the lot number was confirmed with the packaging returned with the device.During visual inspection, the coil delivery wire was seen to be kinked/bent, was detached/separated, and was seen to be stretched.During the functional testing was not performed as coil was detached/separated.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.The reported complaint was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.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 and was prepared as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, the tapered distal end of the introducer sheath was firmly seated in the hub of the microcatheter (xt-17), the rhv was opened enough to allow passage of the device through without damage, the coil was advanced slowly and gently without applying excessive force, and no torque was given where advancing the delivery wire.Analysis of the returned device revealed the main coil had been separated from the delivery wire.The proximal section of the main coil was found to be stretched and the coil delivery wire was found to be kinked/bent.Based on visual inspection, it appears the coil had been manually detached.In the case of this complaint, it is probable that the main coil was advanced against resistance inside the microcatheter during delivery to the aneurysm which caused stretching at the proximal end and premature separation.An assignable cause of procedural factors will be assigned to the as reported main coil prematurely detached/separated during use, main coil stretched, and the coil introducer sheath friction complaint since these issues appear 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.It is likely that additional force was applied on the delivery wire to overcome resistance during the procedure and this caused the delivery wire to kink.Therefore, an assignable cause of handling damage will be assigned to the coil delivery wire kinked/bent since this issue is associated with handling of the product or portion of the product during the clinical procedure.

• Brand Name: TARGET 360 NANO 3MM X 6CM
• 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: 11958445
• Report Number: 3008881809-2021-00229
• Device Sequence Number: 14514836
• Product Code: HCG
• UDI-Device Identifier: 07613252600329
• UDI-Public: 07613252600329
• 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): 08/13/2021

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: 11/16/2023
• Device Model Number: M0035443060
• Device Catalogue Number: M0035443060
• Device Lot Number: 22590370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 08/13/2021
• 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 XT-17 CATHETER (STRYKER); EXCELSIOR XT-17 CATHETER (STRYKER)