MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 1MM X 2CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035431020
Medical Device Problem Codes	Fracture (1260); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
It was reported during the aneurysm embolization procedure, the subject device coil was delivered into the posterior communicating artery (pcom) aneurysm of the left side and detached normally.When withdrew the delivery guidewire, the operator found that the subject coil was not detached completely.The distal part of the subject coil was in the aneurysm and the proximal part was in microcatheter.The operator tried to push the subject coil again but found the delivery wire and the subject coil was separated.Therefore, the operator withdrew the delivery wire and prepared to advance a wire to help to push the subject coil, but after several tries the coil couldn't be filled so finally withdrew it together with the microcatheter and finished the procedure.According to the physician that the subject coil was stretched so it couldn¿t be detached completely.There were no reported clinical consequences to the patient.
Event or Problem Description
It was reported during the aneurysm embolization procedure, the subject device coil was delivered into the posterior communicating artery (pcom) aneurysm of the left side and detached normally.When withdrew the delivery guidewire, the operator found that the subject coil was not detached completely.The distal part of the subject coil was in the aneurysm and the proximal part was in microcatheter.The operator tried to push the subject coil again but found the delivery wire and the subject coil was separated.Therefore, the operator withdrew the delivery wire and prepared to advance a wire to help to push the subject coil, but after several tries the coil couldn't be filled so finally withdrew it together with the micorcatheter and finished the procedure.According to the physician that the subject coil was stretched so it couldn¿t be detached completely.There were no reported clinical consequences to the patient.
Additional Manufacturer Narrative
D4 expiration date - added.D10/h3 product available to stryker ¿ updated.D10 returned to manufacturer on ¿updated.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.The device was returned protruding from the microcatheter.The coil delivery wire was not returned.During analysis, the main coil was removed from the catheter, measured and was within specification.The main coil appeared to be stretched and manually detached as the detachment zone was present.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.Information provided by the customer indicated that the device was confirmed to be in good condition prior to use and was prepared as per the dfu, continuous flush was maintained throughout the clinical procedure.An assignable cause of procedural factors will be assigned to the reported ¿main coil prematurely detached/separated during use', ¿main coil stretched' and ' device difficulty engaging target vessel' as well as the analyzed ¿main coil prematurely detached/separated inside patient' and ¿main coil stretched' as these defects 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.The reported 'coil delivery wire broken/fractured during use' cannot be confirmed as the delivery wire was not returned.An assignable cause of not confirmed has been assigned to ¿coil delivery wire broken/fractured during use'.

• Brand Name: TARGET HELICAL NANO 1MM X 2CM
• 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: 10075480
• Report Number: 3008881809-2020-00152
• Device Sequence Number: 2916217
• Product Code: HCG
• UDI-Device Identifier: 04546540698001
• UDI-Public: 04546540698001
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 08/03/2020

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: 09/07/2022
• Device Model Number: M0035431020
• Device Catalogue Number: M0035431020
• Device Lot Number: 21733405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Initial Date Received by Manufacturer: 05/08/2020
• Supplement Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 05/20/2020
• Supplement Report FDA Received Date: 08/03/2020
• 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: EXCELSIOR SL-10 PRE-SHAPED 45 (STRYKER); SYNCHRO (STRYKER)