Device product

Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.

Z-1453-2014

April 01, 2014

Class I

Product summary

Firm: Micro Therapeutics Inc, Dba Ev3 Neurovascular
Event: Event 67893
Status: Terminated
Classification: Class I
Quantity: 32 units total (23 units in US)
Official record key: device-enforcement:Z-1453-2014

Official wording

Reason: Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.

Code information: PED Model/ Lot FA7735014 / 9879718 FA7742512 / 9864827 FA7150035 / 9855921 FA7735016 / 9856429 FA7742518 / 9856431 FA7730010 / 9869991 FA7737514 / 9855933 FA7742518 / 9860762 FA7732514 / 9873854 FA7737516 / 9858010 FA7745014 / 9874111 FA7735014 / 9855265 FA7740016 / 9859214 FA7745016 / 9879736 FA7735014 / 9875267 FA7740016 / 9879180 FA7747514 / 9868888

Distribution pattern: Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Germany, France, UK, Turkey, Argentina, Canada, Colombia, Mexico, , Austria, Belgium, Denmark, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Russia, Slovakia, Slovenia, Spain, Switzerland, and UAE.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.