Device product
Stryker brand Neuroform 3 Microdelivery Stent System, 4.5 mm X 20 mm, REF Catalog Number: E345020, Model/Product Number: M003450200, Product is manufactured by Boston Scientific Corporation, Fremont, CA and distributed by Stryker Neurovascular, Fremont, CA The Neuroform Microdelivery Stent System is intended for use with embolic coils for the treatment of wide neck, intracranial, saccular aneurysms arising from a parent vessel with a diameter of greater than equal to 2 mm and greater than equal to 4.5 mm that are not amenable to treatment with surgical clipping.
Z-1808-2013
Product summary
- Event
- Event 65654
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23 units
- Official record key
device-enforcement:Z-1808-2013
Official wording
Reason: The device is labeled incorrectly, in that, the device Model Number on the outer carton and inner pouch labels did not match, although both referenced the same lot number. The Model Number on the outer box states UPN M003E345020 (4.5mm x 20 mm Neuroform 3 Stent) while the pouch label states UPN M003E3450300 (4.5mm x 30 mm Neuroform 3 Stent).
Code information: Code: M003450200, Lot 15391019, Expiration Date: 2015-07
Distribution pattern: International Distribution including Austria, China, and Germany.
Derived failure modes
-
Unknown
The device is labeled incorrectly, in that, the device Model Number on the outer carton and inner pouch labels did not match, although both referenced the same lot number. The Model Number on the outer box states UPN M003E345020 (4.5mm x 20 mm Neuroform 3 Stent) while the pouch label states UPN M003E3450300 (4.5mm x 30 mm Neuroform 3 Stent).