MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1.5MM X 2CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035421520
Medical Device Problem Codes	Migration (4003); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that during the procedure, the physician had difficulty deploying the coil (subject device).The subject coil was retrieved but during repositioning, the subject coil inadvertently detached with a coil loop prolapsing into the anterior communicating artery complex.A revascularization device was used to retrieve the prolapsed subject coil.The subject coil was successfully removed from the patient's anatomy.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
B1 adverse event/product problem ¿ corrected.D4 expiration date ¿ added.D9/h3 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.H1 type of reportable event.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 reported complaint was confirmed based on analysis.The device failed to meet specification when received for complaint investigation based on the analyzed anomalies noted to the device.During visual inspection, the main coil appeared to be mechanically detached from the pusher wire and was found to be kinked and stretched.Only the subject coil was returned for analysis.Therefore, functional inspection and detachment testing could not be performed.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.In the case of this complaint, it is most likely that procedural factors during use contributed to difficulty detaching the coil resulting in partial detachment.During attempted repositioning the coil likely kinked and stretched, and then fully detached from the pusher wire due to pushing/pulling forces.An assignable cause of procedural factors will be assigned to the as reported and as analyzed defects since this complaint appears to be associated with a product that met 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.
Event or Problem Description
It was reported that during the procedure, the physician had difficulty deploying the coil (subject device).The subject coil was retrieved but during repositioning, the subject coil inadvertently detached with a coil loop prolapsing into the anterior communicating artery complex.A revascularization device was used to retrieve the prolapsed subject coil.The subject coil was successfully removed from the patient's anatomy.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 NANO 1.5MM 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: 10141128
• Report Number: 3008881809-2020-00172
• Device Sequence Number: 1762307
• Product Code: HCG
• UDI-Device Identifier: 04546540697981
• UDI-Public: 04546540697981
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/12/2020

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: 10/15/2022
• Device Model Number: M0035421520
• Device Catalogue Number: M0035421520
• Device Lot Number: 21837734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020
• Initial Date Received by Manufacturer: 05/24/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 08/12/2020
• 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: AXIUM PRIME COIL (MEDTRONIC); SOLITAIRE REVASCULARIZATION DEVICE (MEDTRONIC)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR