MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1MM X 2CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035421020
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Device was returned for analysis and product lot number was not confirmed as packaging was not returned.During visual inspection, it was noted that the subject coil delivery wire was kinked/bent.The coil was not returned with the device and looked as though the coil had detached mechanically.Functional tests could not be carried out as the coil was detached.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 damage noted to the device would be indicative of the as reported defect.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, preparation/set-up was performed as per the dfu and continuous flush was maintained for the duration of the procedure.The as reported coil in catheter friction was confirmed and the as analyzed main coil prematurely detached/separated during will be assigned procedural factors as the defect appears to be associated with a product that met stryker and design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural or anatomical factors during use.The as analyzed coil delivery wire kinked/bent will be assigned handling damage as the issue is due to handling of the product or portion of the product during the clinical procedure, upon removal of the product from the packaging, or preparation of the product prior to use.
Event or Problem Description
It was reported that during a procedure to treat basilar artery aneurysm, the physician delivered a microcatheter to reach the target lesion and proceeded to frame using coils.When delivering a coil it was noted to pass the y-valve to go into microcatheter but could not be delivered out of the microcatheter distal section.Physician replaced coil and attempted process again with subject coil, but encountered difficulty delivering out of microcatheter.Physician replaced subject coil with another similar device and completed the procedure successfully with no clinical consequences to the patient.Analysis of the device revealed that the subject main coil was prematurely detached/separated during use.

• Brand Name: TARGET 360 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: 10452216
• Report Number: 3008881809-2020-00245
• Device Sequence Number: 3569258
• Product Code: HCG
• UDI-Device Identifier: 04546540697967
• UDI-Public: 04546540697967
• 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
• Report Date (Section B): 08/25/2020

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: 04/23/2022
• Device Model Number: M0035421020
• Device Catalogue Number: M0035421020
• Device Lot Number: 21367548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 08/25/2020
• 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: SL-10 MICROCATHETER (STRYKER); TARGET HELICAL NANO (STRYKER)
• Patient Age: 45 YR