MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 1.5MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035431530
Medical Device Problem Codes	Break (1069); Migration (4003)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned.
Event or Problem Description
It was reported that the subject coil was used as the last coil during embolization procedure for aneurysm located at the anterior communicating artery (acom).The physician had difficulty positioning the subject coil in the target lesion.The physician tried multiple times to adjust the position of the subject coil; however, the subject coil delivery wire broke and was flushed to the distal of the vessel with the main coil and the procedure was stopped.Post procedure computed tomography (ct) showed that the broken delivery wire was in the vessel.A snare device was used during this procedure.There were no clinical consequences reported due to this event.
Event or Problem Description
It was reported that the subject coil was used as the last coil during embolization procedure for aneurysm located at the anterior communicating artery (acom).The physician had difficulty positioning the subject coil in the target lesion.The physician tried multiple times to adjust the position of the subject coil; however, the subject coil delivery wire broke and was flushed to the distal of the vessel with the main coil and the procedure was stopped.Post procedure computed tomography (ct) showed that the broken delivery wire was in the vessel.A snare device was used during this procedure.There were no clinical consequences reported due to this event.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, visual, dimension and functional testing could not be performed.In case of this complaint, it is most likely that the main coil encountered difficulty engaging of the target vessel and later delivery wire broke inside the patient resulting in migration of fragments inside the vessel due to some handling issue or procedural factors encountered during use.It also has been reported that the several reposition attempts were performed along with a non-stryker microcatheter, this may also have contributed to the failures reported.As per additional information, no damage was noted to the device prior to use, an assignable cause of procedural factors was assigned to the as reported issues 'nv ¿ device difficult engaging target vessel', 'nv ¿ un-retrieved device fragments' and 'nv ¿ coil delivery wire broken fractured', as the issues are associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural factors and/or anatomical factors use, the device performance was limited.

• Brand Name: TARGET HELICAL NANO 1.5MM X 3CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7860553
• Report Number: 3008881809-2018-00395
• Device Sequence Number: 13944799
• Product Code: HCG
• UDI-Device Identifier: 04546540698049
• UDI-Public: 04546540698049
• 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): 11/08/2018

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: 03/20/2021
• Device Catalogue Number: M0035431530
• Device Lot Number: 20389305
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/15/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 09/10/2018
• Supplement Report FDA Received Date: 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 80