MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK GDC-10 360 9MM X 20CM SR; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M003346920SR0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage, Cerebral (1889); Hemorrhage, Subarachnoid (1893); Neurological Deficit/Dysfunction (1982)
Date of Event	07/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the sixth of 9 reports.Subject devices remain implanted.
Event or Problem Description
It was reported that 76 hours post coil embolization of an un-ruptured aneurysm located on the middle cerebral artery with 9 coils (subject devices), the patient suffered one side hemiplegia due to hemorrhage.Use of drugs (not specified) was prescribed in order to treat the adverse event.According to the physician, the adverse event of hemiplegia was related to the procedure and to all of the coils.This report concerns the sixth coil.
Additional Manufacturer Narrative
Executive summary: corrected: the type of hemorrhage was subarachnoid hemorrhage, the drugs used were recombinant activated factorvii and nicardipine, and the adverse event occurred 72 hours post-procedure (not 76 hours).Manufacturing date: added.(b)(4).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, physical as well as a functional testing could not be performed.Hemorrhage and neurological deficits are known risks associated with endovascular procedures and noted as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complication was assigned to this event.
Event or Problem Description
It was reported that 72 hours post coil embolization of an un-ruptured aneurysm located on the middle cerebral artery with 9 coils (subject devices), the patient suffered one side hemiplegia due to subarachnoid hemorrhage.Use of drugs (recombinant activated factorvii, nicardipine) was prescribed in order to treat the adverse event.According to the physician, the adverse event of hemiplegia was related to the procedure and to all of the coils.This report concerns the sixth coil.

• Brand Name: GDC-10 360 9MM X 20CM SR
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6809322
• Report Number: 3008881809-2017-00253
• Device Sequence Number: 149767
• Product Code: HCG
• UDI-Device Identifier: 04546540689726
• UDI-Public: (01)04546540689726(17)190430(10)19019877
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K042539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2017

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 Expiration Date: 04/30/2019
• Device Model Number: M003346920SR0
• Device Catalogue Number: M003346920SR0
• Device Lot Number: 19019877
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/25/2017
• Supplement Date Received by Manufacturer: 09/26/2017
• Initial Report FDA Received Date: 08/21/2017
• Supplement Report FDA Received Date: 10/20/2017
• 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: 42 YR
• Patient Weight: 62