MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 5MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035475200
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/24/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure the coil detached prematurely.The physician deployed a stent to secure the coil to the vessel without clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The delivery wire was returned and analysis revealed that it was kinked.In addition the proximal contact was observed to be kinked as well.Microscopy inspection of the delivery wire detachment zone showed that the main coil had detached due to a physical break.A functional testing could not be performed due to the condition of the device.The damage to the delivery wire is likely related to handling of the device during the clinical procedure.Information available indicated that the target coil was confirmed to be in good condition prior to use.It is probable that the device became damaged during the clinical procedure contributing to the reported break limiting its performance.Based on the information available and analysis of the device an assignable cause of operational context was assigned to this investigation.
Event or Problem Description
It was reported that during the procedure the coil detached prematurely.The physician deployed a stent to secure the coil to the vessel without clinical consequences to the patient.

• Brand Name: TARGET 360 SOFT 5MM X 20CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 5960131
• Report Number: 3008881809-2016-00174
• Device Sequence Number: 85239
• Product Code: HCG
• UDI-Device Identifier: 04546540676511
• UDI-Public: (01)04546540676511(17)190531(10)19041227
• Combination Product (Y/N): N
• Initial Reporter Country: LT
• PMA/510(K) Number: K112385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2016

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: 05/31/2019
• Device Catalogue Number: M0035475200
• Device Lot Number: 19041227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/24/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/19/2016
• Supplement Report FDA Received Date: 11/18/2016
• 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: ECHELON MICROCATHETER (EV3)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR