MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK GDC-10 360 5MM X 15CM SR; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M003346515SR0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage, Cerebral (1889); Hemorrhage, Subarachnoid (1893); Neurological Deficit/Dysfunction (1982)

Event Date 07/13/2017

Event Type  Injury  

Manufacturer Narrative

This is the fourth of 9 reports.Subject devices remain implanted.

Event 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 fourth coil.

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).Expiration date: added.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 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 fourth coil.

• Brand Name: GDC-10 360 5MM X 15CM SR
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 6809426
• MDR Text Key: 83191916
• Report Number: 3008881809-2017-00254
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K042539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: M003346515SR0
• Device Lot Number: 19481116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 8 OTHER GDC COILS (STRYKER)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 42 YR
• Patient Weight: 62