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

Catalog Number	M0035431520
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	05/01/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device remains implanted.
Event or Problem Description
It was reported that after coil (subject device) implantation,the thrombosis was occured in the p-com (posterior communicating artery) and it was resolved by thrombectomy using a stent retriever.No further details provided.
Additional Manufacturer Narrative
The device history record (dhr) could not be reviewed because the lot number was not reported.The subject device was not returned for analysis, therefore physical and functional evaluations could not be performed.However, the reported patient thrombosis is a known risk associated with endovascular procedures and noted as such in the device directions for use (dfu).Based on the information available, an assignable cause of known inherent risk of procedure was assigned to this event.
Event or Problem Description
It was reported that after coil (subject device) implatation,the thrombosis was occured in the p-com(posterior communicating artery) and it was resolved by thrombectomy using a stent retriever.No further details provided.

• Brand Name: TARGET HELICAL 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
• MDR Report Key: 7615069
• Report Number: 3008881809-2018-00272
• Device Sequence Number: 13841940
• Product Code: HCG
• UDI-Device Identifier: 04546540698032
• UDI-Public: 04546540698032
• Combination Product (Y/N): N
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: M0035431520
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2018
• Supplement Date Received by Manufacturer: 07/06/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 07/31/2018
• 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: GALAXY 2.5*5 (GALAXY); GALAXY 2.5*5 (GALAXY)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 68 YR