MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 2 MM X 6 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035452060
Medical Device Problem Codes	Material Protrusion/Extrusion (2979); Premature Separation (4045)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device implanted.
Event or Problem Description
It was reported that during coil embolization procedure, the physician pulled back the subject coil and the main coil prematurely detached.Half of the coil remained in the aneurysm while the other half protruded, making a tail on the patient¿s vessel.The physician deployed a stent to prevent the protruded coil from blocking the patient¿s vessel.There were no clinical consequences to the patient reported.
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, dimensional and functional testing could not be performed.In case of this complaint it is possible that the main coil prematurely detached and later protruded while getting pulled back due to some procedural factors encountered during use, possible leading to the as reported issues 'nv - main coil protrusion' and ' nv - main coil prematurely detached separated inside patient'; however, cannot be conclusively determined.The additional information provided by the customer indicated that no damage was noted to the device prior to use and the device was prepared as per direction for use (dfu).An assignable cause of undetermined was assigned to the as reported issues 'nv - main coil protrusion' and ' nv - main coil prematurely detached separated inside patient' as the device was not returned and the review and analysis of all available information failed to indicate as assignable cause.
Event or Problem Description
It was reported that during coil embolization procedure, the physician pulled back the subject coil and the main coil prematurely detached.Half of the coil remained in the aneurysm while the other half protruded, making a tail on the patient¿s vessel.The physician deployed a stent to prevent the protruded coil from blocking the patient¿s vessel.There were no clinical consequences to the patient reported.

• Brand Name: TARGET HELICAL NANO 2 MM X 6 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7858115
• Report Number: 3008881809-2018-00391
• Device Sequence Number: 11097439
• Product Code: HCG
• UDI-Device Identifier: 07613252600381
• UDI-Public: 07613252600381
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2018

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: 04/07/2021
• Device Catalogue Number: M0035452060
• Device Lot Number: 20399150
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/16/2018
• Supplement Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 09/07/2018
• Supplement Report FDA Received Date: 10/10/2018
• 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)
• Outcome Attributed to Adverse Event: Required Intervention