FDA Adverse Event Malfunction Summary report: N

PIPELINE FLEX EMBOLIZATION DEVICE

MDR report key: 6935625 · Received October 10, 2017

Report

Report Number
MW5072655
Event Type
Malfunction
Date Received
October 10, 2017
Date of Event
September 13, 2017
Report Date
September 27, 2017
Manufacturer
MICRO THERAPEUTICS, INC.
Product Code
OUT
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

PT HAD A PIPELINE EMBOLIZATION OF INTRACRANIAL ANEURYSM. AFTER CONFIRMING THE WORKING PROJECTIONS FOR PIPELINE DEPLOYMENT, A 3.25 X 16 MM PIPELINE EMBOLIZATION DEVICE WAS ADVANCED, WHICH WAS DEPLOYED FROM THE PROXIMAL RIGHT MI SEGMENT OF THE RIGHT MIDDLE CEREBRAL ARTERY TO THE CAVERNOUS PERIOPHTHALMIC SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY. DEPLOYMENT OF THE PIPELINE WAS STRAIGHT FORWARD AS THE DEVICE OPENED UP NICELY BY THE USUAL PUSHING MOTION ENTIRELY COVERING THE ANEURYSM. ONCE THE DEVICE WAS FULLY DEPLOYED, IT WAS ATTEMPTED TO READVANCE THE MICROCATHETER THROUGH THE PIPELINE DEVICE OVER THE DELIVERY WIRE TO RETRIEVE THE CAPTURE COIL IN THE MCA; HOWEVER, BECAUSE OF SIGNIFICANT TORTUOSITY OF THE CAVERNOUS OPHTHALMIC SEGMENT, THIS WAS IMPOSSIBLE. THEY THEN REMOVED THE WIRE AND THE MICROCATHETER TOGETHER. HOWEVER, UPON ATTEMPTING TO PULL BACK THE WIRE, THE CAPTURE COIL WAS RETAINED. THEY DECIDED TO SNARE THE CAPTURE COIL, WHICH WAS RETAINED AT THE SUPERIOR M2 DIVISION OF THE RIGHT MIDDLE CEREBRAL ARTERY. THROUGH THE NAVIEN INTERMEDIATE CATHETER AND USING ROADMAP TECHNIQUE, THEY ADVANCED AN XT-27 FLEX MICROCATHETER OVER SYNCHRO-2 STANDARD MICROWIRE AND GENTLY ADVANCED TO SYSTEMS THROUGH THE PIPELINE INTO THE RIGHT MCA NEAR THE PROXIMAL PORTION OF THE CAPTURE COIL. AFTER THIS MICROWIRE WAS REMOVED AND THROUGH THE XT-27 MICROCATHETER, THEY ADVANCED A 2 MM OF MICRO SNARE AND TRIED TO CAPTURE, THE CAPTURE COIL WAS DIFFICULT. THEY ADVANCED THE MICROCATHETER AT DISTAL TIP OF THE CAPTURE COIL AND SNARE IT FROM DISTAL TO PROXIMAL. THEY THEN ADVANCED THE SNARE DEVICE, SNARED THE CAPTURE COIL AND PULLED IT BACK. THE RETRIEVAL MOTION WAS SMOOTHED UNTIL THEY GOT THE CAVERNOUS PORTION PROXIMAL TO THE PIPELINE WHERE THE DEVICE GOT STUCK AT TIP OF THE NAVIEN BUT THEY MANAGED TO PULL IT BACK INTO NAVIEN. IT APPEARS THAT SOME UNRAVELLED MATERIAL OF THE PUSHER RETAINED IN THE CERVICAL CAROTID ARTERY SEGMENT. THIS WAS EXTREMELY TINY AND NOT FLOW LIMITING OR CAUSING STENOSIS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
717334 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. PED-325-16 A210313

Patients

Seq Age Sex Outcome Treatment
1 81 YR