MAUDE Adverse Event Report: STRYKER NEUROVASCULAR TARGET 360 NANO COILS DETACHABLE; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number 542102

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923); Material Protrusion/Extrusion (2979)

Patient Problems Hemorrhage, Intraventricular (1892); Hydrocephalus (3272)

Event Date 09/20/2018

Event Type  malfunction  

Event Description

Coil would not detach.This was the second coil placed in the basilar tip aneurysm.When the delivery system was withdrawn, the first neuro coil was partially dislodged from the aneurysm by the second coil moving.The first was partially protruding from the aneurysm as a result of the dislodgement.The physician had to place a stent to keep coil in place.Patient then required anticoagulants.She later developed a loculated hydrocephalus intraventricular hemorrhage.

• Brand Name: TARGET 360 NANO COILS DETACHABLE
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR; 47900 bayside parkway; fremont CA 94538
• MDR Report Key: 7933500
• MDR Text Key: 122672121
• Report Number: 7933500
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 542102
• Device Catalogue Number: M0035421020
• Device Lot Number: 20620856
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/26/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 15695 DA